Enviar pesquisa
Carregar
Regulatory approval process for medical Devices
•
6 gostaram
•
4,001 visualizações
The QCCP
Seguir
Regulatory approval process for medical Devices
Leia menos
Leia mais
Saúde e medicina
Denunciar
Compartilhar
Denunciar
Compartilhar
1 de 40
Baixar agora
Baixar para ler offline
Recomendados
Regulatory approval process for invitro diagnostics in us
Regulatory approval process for invitro diagnostics in us
Vinod Raj
Medical device regulation US, European Union and India
Medical device regulation US, European Union and India
CSIR-URDIP, NCL Campus, Pune
MDD 93/42/EEC
MDD 93/42/EEC
Pavan Kumar Malwade
ASEAN COUNTRIES.pptx
ASEAN COUNTRIES.pptx
AartiVats5
Medical Device Regulation
Medical Device Regulation
Sam Nixon
The EU’s Medical Device Regulation
The EU’s Medical Device Regulation
Stefano Bolletta
IDE Application Process and Best Practices
IDE Application Process and Best Practices
CFTCC
Risk Based Classification of Medical Devices and grouping
Risk Based Classification of Medical Devices and grouping
Paulyne Wairimu
Recomendados
Regulatory approval process for invitro diagnostics in us
Regulatory approval process for invitro diagnostics in us
Vinod Raj
Medical device regulation US, European Union and India
Medical device regulation US, European Union and India
CSIR-URDIP, NCL Campus, Pune
MDD 93/42/EEC
MDD 93/42/EEC
Pavan Kumar Malwade
ASEAN COUNTRIES.pptx
ASEAN COUNTRIES.pptx
AartiVats5
Medical Device Regulation
Medical Device Regulation
Sam Nixon
The EU’s Medical Device Regulation
The EU’s Medical Device Regulation
Stefano Bolletta
IDE Application Process and Best Practices
IDE Application Process and Best Practices
CFTCC
Risk Based Classification of Medical Devices and grouping
Risk Based Classification of Medical Devices and grouping
Paulyne Wairimu
EU MDR
EU MDR
RohitParkale
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Swapnil Fernandes
ISO 14155.pdf
ISO 14155.pdf
Zeelshah2258
Regulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devices
Atul Bhombe
Medical devices
Medical devices
Tarun Kumar Reddy
UDI
UDI
Pavan Kumar Malwade
Regulation of Medical Devices in US
Regulation of Medical Devices in US
Ankit Geete
The European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final text
pi
Medical Devices Product Lifecycle
Medical Devices Product Lifecycle
SanthiNori1
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Akshay Anand
CE marking and CE certification
CE marking and CE certification
meddevicemarking
medical device regulatory approval in USA
medical device regulatory approval in USA
Suraj Pamadi
Medical devices CHINA
Medical devices CHINA
Parul Institute of Pharmacy
Medical devices and IVD'S
Medical devices and IVD'S
SanthiNori1
European_Union.ppt.Nikhil[1].pptx
European_Union.ppt.Nikhil[1].pptx
NikhilBorade5
Drug approval process in japan
Drug approval process in japan
Manish kumar
GHTF
GHTF
KDivya11
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Pallavi Christeen
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
CSIR-URDIP, NCL Campus, Pune
STED
STED
SanthiNori1
Lancashire SME workshop - regulation and medical device workshop
Lancashire SME workshop - regulation and medical device workshop
Innovation Agency
mHealth Summit EU 2015
mHealth Summit EU 2015
3GDR
Mais conteúdo relacionado
Mais procurados
EU MDR
EU MDR
RohitParkale
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Swapnil Fernandes
ISO 14155.pdf
ISO 14155.pdf
Zeelshah2258
Regulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devices
Atul Bhombe
Medical devices
Medical devices
Tarun Kumar Reddy
UDI
UDI
Pavan Kumar Malwade
Regulation of Medical Devices in US
Regulation of Medical Devices in US
Ankit Geete
The European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final text
pi
Medical Devices Product Lifecycle
Medical Devices Product Lifecycle
SanthiNori1
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Akshay Anand
CE marking and CE certification
CE marking and CE certification
meddevicemarking
medical device regulatory approval in USA
medical device regulatory approval in USA
Suraj Pamadi
Medical devices CHINA
Medical devices CHINA
Parul Institute of Pharmacy
Medical devices and IVD'S
Medical devices and IVD'S
SanthiNori1
European_Union.ppt.Nikhil[1].pptx
European_Union.ppt.Nikhil[1].pptx
NikhilBorade5
Drug approval process in japan
Drug approval process in japan
Manish kumar
GHTF
GHTF
KDivya11
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Pallavi Christeen
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
CSIR-URDIP, NCL Campus, Pune
STED
STED
SanthiNori1
Mais procurados
(20)
EU MDR
EU MDR
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
ISO 14155.pdf
ISO 14155.pdf
Regulatory requirement and approval procedure for medical devices
Regulatory requirement and approval procedure for medical devices
Medical devices
Medical devices
UDI
UDI
Regulation of Medical Devices in US
Regulation of Medical Devices in US
The European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final text
Medical Devices Product Lifecycle
Medical Devices Product Lifecycle
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
CE marking and CE certification
CE marking and CE certification
medical device regulatory approval in USA
medical device regulatory approval in USA
Medical devices CHINA
Medical devices CHINA
Medical devices and IVD'S
Medical devices and IVD'S
European_Union.ppt.Nikhil[1].pptx
European_Union.ppt.Nikhil[1].pptx
Drug approval process in japan
Drug approval process in japan
GHTF
GHTF
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
STED
STED
Semelhante a Regulatory approval process for medical Devices
Lancashire SME workshop - regulation and medical device workshop
Lancashire SME workshop - regulation and medical device workshop
Innovation Agency
mHealth Summit EU 2015
mHealth Summit EU 2015
3GDR
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)
Greenlight Guru
IVDR Readiness Checklist
IVDR Readiness Checklist
Greenlight Guru
EU MDD.pptx
EU MDD.pptx
AartiVats5
Future of EU In Vitro Diagnostics Regulation
Future of EU In Vitro Diagnostics Regulation
Erik Vollebregt
Point of-care, biosensors & mobile diagnostics europe 2019
Point of-care, biosensors & mobile diagnostics europe 2019
Erik Vollebregt
Pjr Short Ce Presentation
Pjr Short Ce Presentation
Scott Grossman
Cathal Brennan , Medical Device Assessor- Human Products Authorisation and Re...
Cathal Brennan , Medical Device Assessor- Human Products Authorisation and Re...
Investnet
Eu hot topics alliance presentation 2
Eu hot topics alliance presentation 2
Erik Vollebregt
Medical devices: 7 steps to CE-mark, and post-market surveillance
Medical devices: 7 steps to CE-mark, and post-market surveillance
Christian Johner
Eu hot topics alliance presentation
Eu hot topics alliance presentation
Erik Vollebregt
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
Erik Vollebregt
PECB Webinar: The challenges of medical devices and laboratory quality manage...
PECB Webinar: The challenges of medical devices and laboratory quality manage...
PECB
ISO 13485 Medical Manufature.pdf
ISO 13485 Medical Manufature.pdf
demingcertificationa
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB
ISO 13485 Certification.pdf
ISO 13485 Certification.pdf
demingcertificationa
Easy medical devices podcast self tests ivdr
Easy medical devices podcast self tests ivdr
Erik Vollebregt
ISO 16061_2015 Instrumentation for use in Association With Non-Active surgica...
ISO 16061_2015 Instrumentation for use in Association With Non-Active surgica...
demingcertificationa
Ekram_Galeti_Thesis_Final_Presentation
Ekram_Galeti_Thesis_Final_Presentation
Ekram Galeti
Semelhante a Regulatory approval process for medical Devices
(20)
Lancashire SME workshop - regulation and medical device workshop
Lancashire SME workshop - regulation and medical device workshop
mHealth Summit EU 2015
mHealth Summit EU 2015
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)
IVDR Readiness Checklist
IVDR Readiness Checklist
EU MDD.pptx
EU MDD.pptx
Future of EU In Vitro Diagnostics Regulation
Future of EU In Vitro Diagnostics Regulation
Point of-care, biosensors & mobile diagnostics europe 2019
Point of-care, biosensors & mobile diagnostics europe 2019
Pjr Short Ce Presentation
Pjr Short Ce Presentation
Cathal Brennan , Medical Device Assessor- Human Products Authorisation and Re...
Cathal Brennan , Medical Device Assessor- Human Products Authorisation and Re...
Eu hot topics alliance presentation 2
Eu hot topics alliance presentation 2
Medical devices: 7 steps to CE-mark, and post-market surveillance
Medical devices: 7 steps to CE-mark, and post-market surveillance
Eu hot topics alliance presentation
Eu hot topics alliance presentation
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
PECB Webinar: The challenges of medical devices and laboratory quality manage...
PECB Webinar: The challenges of medical devices and laboratory quality manage...
ISO 13485 Medical Manufature.pdf
ISO 13485 Medical Manufature.pdf
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...
ISO 13485 Certification.pdf
ISO 13485 Certification.pdf
Easy medical devices podcast self tests ivdr
Easy medical devices podcast self tests ivdr
ISO 16061_2015 Instrumentation for use in Association With Non-Active surgica...
ISO 16061_2015 Instrumentation for use in Association With Non-Active surgica...
Ekram_Galeti_Thesis_Final_Presentation
Ekram_Galeti_Thesis_Final_Presentation
Mais de The QCCP
Section 14 Collection and Disposal of Waste.pdf
Section 14 Collection and Disposal of Waste.pdf
The QCCP
Section 13 Special Procedures Equipment and Products.pdf
Section 13 Special Procedures Equipment and Products.pdf
The QCCP
Section 12 Special Procedures Environment.pdf
Section 12 Special Procedures Environment.pdf
The QCCP
Section 11 Cleaning, disinfection and sterilisation.pdf
Section 11 Cleaning, disinfection and sterilisation.pdf
The QCCP
Section 10 Management of Body Fluids.pdf
Section 10 Management of Body Fluids.pdf
The QCCP
Section 9 Occupational Exposure Management and PPE.pdf
Section 9 Occupational Exposure Management and PPE.pdf
The QCCP
Section 8 Hand Hygiene.pdf
Section 8 Hand Hygiene.pdf
The QCCP
Section 7: Client Consultation and Aftercare.pdf
Section 7: Client Consultation and Aftercare.pdf
The QCCP
Section 6: Legal Requirements.pdf
Section 6: Legal Requirements.pdf
The QCCP
Section 5 The Chain of Infection.pdf
Section 5 The Chain of Infection.pdf
The QCCP
Section 4 Common non-infectious hazards and their sources.pdf
Section 4 Common non-infectious hazards and their sources.pdf
The QCCP
Section 3 - The skin - Its reaction to injury and its role in defence against...
Section 3 - The skin - Its reaction to injury and its role in defence against...
The QCCP
Foundation course in dermal fillers hf
Foundation course in dermal fillers hf
The QCCP
Fab pres20aug
Fab pres20aug
The QCCP
Biostimulant dermal fillers
Biostimulant dermal fillers
The QCCP
Ace17 lips
Ace17 lips
The QCCP
Anatomy toxin injections
Anatomy toxin injections
The QCCP
MHRA Yellow Card Scheme
MHRA Yellow Card Scheme
The QCCP
Guidance for aesthetic medicine qualifications
Guidance for aesthetic medicine qualifications
The QCCP
Unit 7: Principles of Dermal Filler Use in Aesthetic Medicine
Unit 7: Principles of Dermal Filler Use in Aesthetic Medicine
The QCCP
Mais de The QCCP
(20)
Section 14 Collection and Disposal of Waste.pdf
Section 14 Collection and Disposal of Waste.pdf
Section 13 Special Procedures Equipment and Products.pdf
Section 13 Special Procedures Equipment and Products.pdf
Section 12 Special Procedures Environment.pdf
Section 12 Special Procedures Environment.pdf
Section 11 Cleaning, disinfection and sterilisation.pdf
Section 11 Cleaning, disinfection and sterilisation.pdf
Section 10 Management of Body Fluids.pdf
Section 10 Management of Body Fluids.pdf
Section 9 Occupational Exposure Management and PPE.pdf
Section 9 Occupational Exposure Management and PPE.pdf
Section 8 Hand Hygiene.pdf
Section 8 Hand Hygiene.pdf
Section 7: Client Consultation and Aftercare.pdf
Section 7: Client Consultation and Aftercare.pdf
Section 6: Legal Requirements.pdf
Section 6: Legal Requirements.pdf
Section 5 The Chain of Infection.pdf
Section 5 The Chain of Infection.pdf
Section 4 Common non-infectious hazards and their sources.pdf
Section 4 Common non-infectious hazards and their sources.pdf
Section 3 - The skin - Its reaction to injury and its role in defence against...
Section 3 - The skin - Its reaction to injury and its role in defence against...
Foundation course in dermal fillers hf
Foundation course in dermal fillers hf
Fab pres20aug
Fab pres20aug
Biostimulant dermal fillers
Biostimulant dermal fillers
Ace17 lips
Ace17 lips
Anatomy toxin injections
Anatomy toxin injections
MHRA Yellow Card Scheme
MHRA Yellow Card Scheme
Guidance for aesthetic medicine qualifications
Guidance for aesthetic medicine qualifications
Unit 7: Principles of Dermal Filler Use in Aesthetic Medicine
Unit 7: Principles of Dermal Filler Use in Aesthetic Medicine
Último
Independent Bangalore Call Girls (Adult Only) 💯Call Us 🔝 7304373326 🔝 💃 Escor...
Independent Bangalore Call Girls (Adult Only) 💯Call Us 🔝 7304373326 🔝 💃 Escor...
Sheetaleventcompany
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Sheetaleventcompany
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
gragneelam30
💰Call Girl In Bangalore☎️7304373326💰 Call Girl service in Bangalore☎️Bangalor...
💰Call Girl In Bangalore☎️7304373326💰 Call Girl service in Bangalore☎️Bangalor...
Sheetaleventcompany
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Dipal Arora
(RIYA)🎄Airhostess Call Girl Jaipur Call Now 8445551418 Premium Collection Of ...
(RIYA)🎄Airhostess Call Girl Jaipur Call Now 8445551418 Premium Collection Of ...
TanyaAhuja34
Kolkata Call Girls Shobhabazar 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Gir...
Kolkata Call Girls Shobhabazar 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Gir...
Namrata Singh
Chandigarh Call Girls Service ❤️🍑 9809698092 👄🫦Independent Escort Service Cha...
Chandigarh Call Girls Service ❤️🍑 9809698092 👄🫦Independent Escort Service Cha...
Sheetaleventcompany
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Sheetaleventcompany
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
perfect solution
Premium Call Girls Dehradun {8854095900} ❤️VVIP ANJU Call Girls in Dehradun U...
Premium Call Girls Dehradun {8854095900} ❤️VVIP ANJU Call Girls in Dehradun U...
Sheetaleventcompany
Cara Menggugurkan Kandungan Dengan Cepat Selesai Dalam 24 Jam Secara Alami Bu...
Cara Menggugurkan Kandungan Dengan Cepat Selesai Dalam 24 Jam Secara Alami Bu...
Cara Menggugurkan Kandungan 087776558899
ANATOMY AND PHYSIOLOGY OF REPRODUCTIVE SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF REPRODUCTIVE SYSTEM.pptx
Swetaba Besh
Call girls Service Phullen / 9332606886 Genuine Call girls with real Photos a...
Call girls Service Phullen / 9332606886 Genuine Call girls with real Photos a...
call girls hydrabad
Circulatory Shock, types and stages, compensatory mechanisms
Circulatory Shock, types and stages, compensatory mechanisms
MedicoseAcademics
Cardiac Output, Venous Return, and Their Regulation
Cardiac Output, Venous Return, and Their Regulation
MedicoseAcademics
💚Reliable Call Girls Chandigarh 💯Niamh 📲🔝8868886958🔝Call Girl In Chandigarh N...
💚Reliable Call Girls Chandigarh 💯Niamh 📲🔝8868886958🔝Call Girl In Chandigarh N...
Sheetaleventcompany
Bhawanipatna Call Girls 📞9332606886 Call Girls in Bhawanipatna Escorts servic...
Bhawanipatna Call Girls 📞9332606886 Call Girls in Bhawanipatna Escorts servic...
Dipal Arora
Call Girls Mussoorie Just Call 8854095900 Top Class Call Girl Service Available
Call Girls Mussoorie Just Call 8854095900 Top Class Call Girl Service Available
Janvi Singh
Race Course Road } Book Call Girls in Bangalore | Whatsapp No 6378878445 VIP ...
Race Course Road } Book Call Girls in Bangalore | Whatsapp No 6378878445 VIP ...
dishamehta3332
Último
(20)
Independent Bangalore Call Girls (Adult Only) 💯Call Us 🔝 7304373326 🔝 💃 Escor...
Independent Bangalore Call Girls (Adult Only) 💯Call Us 🔝 7304373326 🔝 💃 Escor...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Gorgeous Call Girls Dehradun {8854095900} ❤️VVIP ROCKY Call Girls in Dehradun...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
Call Girls Bangalore - 450+ Call Girl Cash Payment 💯Call Us 🔝 6378878445 🔝 💃 ...
💰Call Girl In Bangalore☎️7304373326💰 Call Girl service in Bangalore☎️Bangalor...
💰Call Girl In Bangalore☎️7304373326💰 Call Girl service in Bangalore☎️Bangalor...
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Shahdol Just Call 8250077686 Top Class Call Girl Service Available
(RIYA)🎄Airhostess Call Girl Jaipur Call Now 8445551418 Premium Collection Of ...
(RIYA)🎄Airhostess Call Girl Jaipur Call Now 8445551418 Premium Collection Of ...
Kolkata Call Girls Shobhabazar 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Gir...
Kolkata Call Girls Shobhabazar 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Gir...
Chandigarh Call Girls Service ❤️🍑 9809698092 👄🫦Independent Escort Service Cha...
Chandigarh Call Girls Service ❤️🍑 9809698092 👄🫦Independent Escort Service Cha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Premium Call Girls Nagpur {9xx000xx09} ❤️VVIP POOJA Call Girls in Nagpur Maha...
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
Premium Call Girls Dehradun {8854095900} ❤️VVIP ANJU Call Girls in Dehradun U...
Premium Call Girls Dehradun {8854095900} ❤️VVIP ANJU Call Girls in Dehradun U...
Cara Menggugurkan Kandungan Dengan Cepat Selesai Dalam 24 Jam Secara Alami Bu...
Cara Menggugurkan Kandungan Dengan Cepat Selesai Dalam 24 Jam Secara Alami Bu...
ANATOMY AND PHYSIOLOGY OF REPRODUCTIVE SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF REPRODUCTIVE SYSTEM.pptx
Call girls Service Phullen / 9332606886 Genuine Call girls with real Photos a...
Call girls Service Phullen / 9332606886 Genuine Call girls with real Photos a...
Circulatory Shock, types and stages, compensatory mechanisms
Circulatory Shock, types and stages, compensatory mechanisms
Cardiac Output, Venous Return, and Their Regulation
Cardiac Output, Venous Return, and Their Regulation
💚Reliable Call Girls Chandigarh 💯Niamh 📲🔝8868886958🔝Call Girl In Chandigarh N...
💚Reliable Call Girls Chandigarh 💯Niamh 📲🔝8868886958🔝Call Girl In Chandigarh N...
Bhawanipatna Call Girls 📞9332606886 Call Girls in Bhawanipatna Escorts servic...
Bhawanipatna Call Girls 📞9332606886 Call Girls in Bhawanipatna Escorts servic...
Call Girls Mussoorie Just Call 8854095900 Top Class Call Girl Service Available
Call Girls Mussoorie Just Call 8854095900 Top Class Call Girl Service Available
Race Course Road } Book Call Girls in Bangalore | Whatsapp No 6378878445 VIP ...
Race Course Road } Book Call Girls in Bangalore | Whatsapp No 6378878445 VIP ...
Regulatory approval process for medical Devices
1.
AKSHAY ANAND M I
Year – Master of Pharmacy Pharmaceutical Regulatory Affairs JSS College Of Pharmacy Mysuru 570015, Karnataka REGULATORYAPPROVAL PROCESSFOR MEDICALDEVICESINEUROPEANUNION ©2015 akshayanand
2.
ASPECTS ©2015 akshayanand • Medical Devices
–What are they? • European Union – An Overview • EU Directives that impact Medical Devices • Medical Devices as defined by EU • Classification of Medical Devices as per EU • The CE Certification • The Registration Process for MD • The ProcessTimeline for Registration OF THIS PRESENTATION
3.
01 • A medical
device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions • It does not achieve its purposes through chemical action within or on the body. • Medical devices vary greatly in complexity and application. • The design of medical devices constitutes a major segment of the field of biomedical engineering. • Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. • The global medical device market reached roughly $209 billion in 2006. ©2015 akshayanand
4.
02 ©2015 akshayanand
5.
03 • 28 member
states plus European FreeTrade Association members. • 24 languages. • Population of more than 500 million people. • GDP of $18.124 trillion. • Euro, the currency equalling 71.47 Indian Rupee per unit. ©2015 akshayanand
6.
04 • Medical Devices
(MDD) 93/42/EEC • Covers the bulk of medical devices marketed in the EU • Examples: orthopaedic implants, heart valves, medical software ©2015 akshayanand • Active Implantable Medical Devices (AIMDD) 90/385/EEC • Covers devices that require external power sources in order to function properly • Examples: pacemakers, implantable defibrillators • InVitro Diagnostics (IVDD) 98/79/EC • Covers devices used for the examination of specimens taken from the human body • Examples: pregnancy self-testing strips, blood glucose self-testing strips
7.
05 ©2015 akshayanand • Personal Protective
Equipment 89/686/EEC • LowVoltage 2006/95/EC • Electromagnetic Compatibility 2004/108/EC • Blood Product Directive 2002/98/EC • AnimalTissue Use in Medical Devices 2003/32/EC • HumanTissue Products Directives 2004 & 2005 • Breast Implants Reclassification Directive 2003/12/EC • Hip, Knee, Shoulder Joint Replacement Reclassification Directive 2005/50/EC
8.
06 This guidance document
under Directive 93/42/EEC on Medical Devices provides definition of Medical Devices to include the following: Medical Devices: Guidance Document MEDDEV 2.1/1 APRIL 1994 a. Devices – Accessory b. Medical Purpose c. Customizing d. Medical –Toiletry Purpose e. Aids for Handicapped Persons f. Software g. Multipurpose Products ©2015 akshayanand
9.
07 • The classification
of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. • This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect. These criteria can then be applied to a vast range of different medical devices and technologies. • These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC. Medical Devices: Guidance Document MEDDEV 2.4/1 Rev.8 JULY 2001 MEDDEV 2.4/1 Rev.9 JUNE 2010 ©2015 akshayanand
10.
• The CE
mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. • The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. • This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. • It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States. • It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. • The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives. 08 ©2015 akshayanand
11.
09 ©2015 akshayanand
12.
10 ©2015 akshayanand KEY PLAYERSIN THE CE
MARKING PROCESS(REGULATORY APPROVAL PROCESS FOR MEDICAL DEVICES) • Manufacturers and Subcontractors • Competent Authorities • Notified Bodies • Authorized Representatives • Distributors
13.
11 ©2015 akshayanand • Competent Authorities
are entities enforcing Medical Device Directives at the national level in each EU member state. • Member states and their Competent Authorities each have their own interpretations of how Directives should be carried out. • Manufacturers seeking to sell in more than one EU member state should take this into account.
14.
12 ©2015 akshayanand • Notified Bodies
are authorized to audit manufacturers’ quality systems and test/review devices for compliance with applicable EU Directives and standards. • Their responsibilities include: • Advising on device classification and ConformityAssessment routes • Pre-assessment of devices • Product and quality system evaluation • Concluding and evaluating manufacturers’Corrective Actions • Issuance of certifications • Maintaining programmed surveillance of devices in the EU
15.
13 ©2015 akshayanand • Required for
any firm without a location in the EU. • Their responsibilities include: • Liaising between manufacturers and Competent Authorities • Listing their names on clients’ device labels and packaging • Notifying Competent Authorities of manufacturers’ and devices’ names • KeepingTechnical Files/Design Dossiers available for review by Competent Authorities • Participating in vigilance/post-market surveillance procedures EC REP
16.
14 ©2015 akshayanand Identify Directives and
Regulations appropriate for your device Classify your device according to MDD Annex IX Implement Quality System in compliance with ISO 13485. PrepareTechnical File or Design Dossier demonstrating compliance with MDD 93/42/EEC.
17.
15 ©2015 akshayanand Appoint your Authorized
Representative. Have Notified Body audit your Quality System andTechnical File or Design Dossier. Register your device with Competent Authorities if necessary. Prepare Declaration of Conformity and affix CE Marking to your device.
18.
16 ©2015 akshayanand • First, determine
which Medical Device Directive (MDD, AIMDD or IVDD) applies to your device. • Then determine device classification using Annex IX of MDD 93/42/EEC. Class I Non-Sterile Class I Non-Measuring Class I Sterile Class I Measuring Low-risk, non-invasive devices such as non-sterile wound dressings and stethoscopes
19.
17 ©2015 akshayanand Class IIa Medium-risk, short-term
invasive devices such as tracheal tubes and lancets Class IIb Higher-risk, often longer-term surgically invasive, sometimes implantable devices including intra-ocular lenses and surgical lasers Class III Highest-risk devices, including all active implantable devices such as replacement heart valves and vascular stents
20.
18 ©2015 akshayanand • MDD 93/42/EEC
Annex IX contains 18 rules for medical device classification based on factors including the following: • Device’s intended use • Active versus non-active functionality • Device’s duration of contact with patient • Degree of invasiveness • Part of body contacted by device • Special situations
21.
19 ©2015 akshayanand • Duration of
Contact Criteria • Less than 60 minutes =Transient • Less than 30 days = Short-term • More than 30 days = Long-term • Degree of InvasivenessCriteria • Application to body surface versus an orifice • Surgically invasive or non-invasive • Implantable Determining your device’s duration of contact and degree of invasiveness will help determine how to classify the device.
22.
20 ©2015 akshayanand ShortTerm LongTerm LongTerm Transient Transient Medium-Risk Medium-Risk High-Risk Low-Risk Low-Risk Class IIa Class IIb Class
III Class I Sterile/Measuring Class I Non-Sterile/Non-Measuring
23.
21 ©2015 akshayanand Manufacturers of Class
I sterile/measuring, IIa, IIb and III devices must implement quality management systems (QMS) (in compliance with Annex II orV of the MDD). Most manufacturers meet this requirement using ISO 13485.
24.
22 ©2015 akshayanand Phase I: Quality
system preparation and development • Management buy-in • Assign resources and staff • Conduct gap analysis • Develop quality manual and documentation controls Phase II: Implementation • Employee training • Internal auditing • Corrective and preventative actions Phase III: Registration • Registration audit performed by Notified Body • Final ISO 13485 certification
25.
23 ©2015 akshayanand • All Class
I, IIa and IIb device manufacturers must prepareTechnical Files containing data to demonstrate MDD 93/42/EEC compliance. • Class III device manufacturers must prepare Design Dossiers to demonstrate compliance to MDD. • All manufacturers must have clinical data to demonstrate compliance to MDD.
26.
24 ©2015 akshayanand 1 Description of product
family and justification for why your device falls into that family 2 Device intended use 3 Description of device components, specifications, packaging and literature 4 Device manufacturing Process 5 List of accessories to your device 6 Location of design responsibility and manufacturing facilities 7 Classification along with rationale for classification
27.
25 ©2015 akshayanand 8 Chosen compliance
route according to applicable Directive(s) 9 Declaration of Conformity stating manufacturer’s compliance with applicable Directive(s) 10 Shelf life and environmental limitations of device 11 Retention of quality assurance, Competent Authority and Notified Body records 12 Vigilance reporting and Medical Device Reporting procedures 13 How and when to contact Competent Authorities 14 Name of and contract with yourAuthorized Representative
28.
26 ©2015 akshayanand 15 Subcontractor names
and addresses if applicable 16 Essential Requirements 17 Design input specifications 18 Application and references to Standards and Guidelines 19 Testing results and clinical evaluations 20 Risk analysis 21 Instructions for Use and Labeling
29.
27 ©2015 akshayanand • EU regulators
have increased their requirements for clinical data even for Class I medical devices in recent years. • In many cases, manufacturers must submit Clinical Evaluation Summary Reports that verify the safety and performance of their products along withTechnical Files or Design Dossiers.
30.
28 ©2015 akshayanand Manufacturers with no
offices in the EU must appoint Authorized Representatives (EC REPs) to interact with regulators on their behalf.
31.
29 ©2015 akshayanand • Registering your
device with Competent Authorities before commercialization • Serving as primary point of contact with all EU Competent Authorities • Keeping a current copy of yourTechnical File/Design Dossier available for inspections by Competent Authorities • Authorizing you to place EC REP name and address on your device labels, packaging and instructions for use • Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities • Representing you before the European Commission in the event that your product is withdrawn in a member state • Protecting the confidentiality of your product information • Maintaining reports on clinical evaluation data for review by Competent Authorities • Communicating with Competent Authorities on serious device incidents or FSCAs
32.
30 ©2015 akshayanand Following appointment of
your EC REP, your quality system and Technical File/Design Dossier must be audited by a Notified Body. Upon Successful completion of your audit, the Notified Body will issue a CE Certificate. Manufacturers of Class I Non-sterile/Non-measuring devices self-declare MDD conformity and do not require CE Marking certificates. Class IIa Class IIb Class IIIClass I S/M
33.
31 ©2015 akshayanand Class I device
manufacturers must register with the Competent Authority of the country where their EC REPs are based. Class I S/MClass I NS/NM Class IIa Class IIb Class III Some EU member states do not require registration of Class IIa, IIb or III devices with Competent Authorities. Other countries do not require registration of devices.
34.
32 ©2015 akshayanand • In order
to complete the CE Marking process, all manufacturers must prepare a Declaration of Conformity stating their device is in compliance with all applicable Directives. • Upon completion of your Declaration of Conformity, you may affix CE Marking to your product.
35.
33 ©2015 akshayanand Product Identification Manufacturer Identification EC
REP Information Applicable Directives
36.
34 ©2015 akshayanand • EU member
states MAY require labeling information be made available in their local languages or another European Community language to patients and users in accordance with Annex I, point 13 of the MDD. • All languages subject to subsidiarity All EU member states require device labeling in their official languages Label information in yourTechnical File should only appear in ONE language
37.
35 ©2015 akshayanand Source: EmergoGroup.com Device Classification in Europe Wait
Time after submission until approval is granted Validity Period for CE Marking Certificate Advance Start Time for Registration Renewal Complexity of Registration Process Overall Cost of gaining Regulatory Approval Class I NS/NM <1 Month No Expiry Not Applicable Class I S/M 3-5 Months 3 Years 2 Months Class IIa 3-5 Months 3 Years 2 Months Class IIb 3-6 Months 3 Years 2 Months Class III 6-9 Months 3 Years 2 Months Simple Complex Low High Simple Complex Low High Simple Complex Low High Simple Complex Low High Simple Complex Low High
38.
36 ©2015 akshayanand • PMS required
for all medical devices sold in the EU • Manufacturers are required to develop proactive plans for PMS • PMS plans should include reviews of market and field data, complaints and corrective actions • Systematic records of PMS findings must be kept • Purpose ofVigilance Requirements: • Protecting public health and safety • Evaluating incidents to prevent recurrence • Determining effectiveness of corrective actions taken • Monitoring and learning from experience • Vigilance Requirements for Manufacturers: • Establish and maintain systematic procedures to review experience gained from devices in the post-production phase • Implement appropriate means to apply any necessary corrective actions
39.
37 • https://en.wikipedia.org/wiki/Medical_device -
Wikipedia article on Medical Devices • http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF – Official EU Document : Council Directive 93/42/EEC • http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm - Guidance MEDDEVs Online Directory • http://ec.europa.eu/health/medical-devices/files/meddev/2_1-1___04-1994_en.pdf - Guidance Document MEDDEV 2.1/1April 1994 • http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf - Guidance Document MEDDEV 2.4/1 Rev.8 July 2001 • http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf - Guidance Document MEDDEV 2.4/1 Rev.9 June 2010 • https://en.wikipedia.org/wiki/CE_marking- Wikipedia article on CE Certification • http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf - Official EU Document : Annex IX of Council Directive 93/42/EEC • http://ec.europa.eu/health/medical-devices/faq/market_en.htm - Information about the Medical Device Registration on the Official Website of European Commission • http://medicaldevices.bsigroup.com/en-GB/our-services/ce-marking/ - Information about CE Marking Approval for Medical Devices in Europe • http://www.emergogroup.com/resources/europe-process-chart - Europe CE Approval Process for Medical Devices – Charts &Timelines ©2015 akshayanand
40.
thankyou!axayanand@gmail.com
Baixar agora