IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
In-vitro diagnostic regulation overview as per FDA , including in-vitro defination , classification , examples , general control, special control , pre market notification , DeNovo classification , PMA , 510k or premarket notification , risk based classification
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Dai Google Glass agli occhi bionici stampati in 3D: aspetti giuridici ed etic...Maria Livia Rizzo
L’Internet of Things e i dispositivi indossabili non solo incarnano una tendenza nel campo dell’innovazione, ma rappresentano il futuro del mercato tecnologico. Allo stesso modo, la tecnica di stampa in 3D di parti del corpo umano – sane, migliorate o persino potenziate – ha la capacità di rivoluzionare il contesto sanitario e di riprogettare la condizione umana.
Nell’ambito sia delle wearable technologies sia del bioprinting tra le innovazioni più invasive emergono quelle legate alla realtà aumentata e al potenziamento visivo: Google Glass da un lato, e occhio bionico dall’altro.
L’incontro ha lo scopo di fare chiarezza sullo stato dell’arte e di analizzare le questioni giuridiche ed etiche che possono di fatto porsi come ostacolo alla diffusione di queste tecnologie.
In-vitro diagnostic regulation overview as per FDA , including in-vitro defination , classification , examples , general control, special control , pre market notification , DeNovo classification , PMA , 510k or premarket notification , risk based classification
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Dai Google Glass agli occhi bionici stampati in 3D: aspetti giuridici ed etic...Maria Livia Rizzo
L’Internet of Things e i dispositivi indossabili non solo incarnano una tendenza nel campo dell’innovazione, ma rappresentano il futuro del mercato tecnologico. Allo stesso modo, la tecnica di stampa in 3D di parti del corpo umano – sane, migliorate o persino potenziate – ha la capacità di rivoluzionare il contesto sanitario e di riprogettare la condizione umana.
Nell’ambito sia delle wearable technologies sia del bioprinting tra le innovazioni più invasive emergono quelle legate alla realtà aumentata e al potenziamento visivo: Google Glass da un lato, e occhio bionico dall’altro.
L’incontro ha lo scopo di fare chiarezza sullo stato dell’arte e di analizzare le questioni giuridiche ed etiche che possono di fatto porsi come ostacolo alla diffusione di queste tecnologie.
Come affrontare i rischi per la salute legati alla stampa 3DMaria Livia Rizzo
Come affrontare i rischi per la salute legati alla stampa 3D. Utente ferito da prodotto stampato in 3D. Rischi per la salute durante il processo di stampa in 3D. Responsabilità da prodotto. Assicurazioni.
L'attività medica: prevenzione e soluzione dei conflitti.Maria Livia Rizzo
Bologna, 25 maggio 2012
Aula Clinica Medica - A.Osp. Sant'Orsola - Malpighi
Alma Mater Studiorum - Università di Bologna
Modelli e strumenti di supporto alla scelta informata del paziente. Un argine alla medicina difensiva.
La responsabilità nell'utilizzo di applicazioni di mhealthMaria Livia Rizzo
Presentazione inerente al seminario "Un aspetto emergente dell'e-health: le app medicali" del master universitario di I livello "E-health società digitale e organizzazione sanitaria" del Cirsfid - Università di Bologna.
Paralisi cerebrale: orientamenti della giurisprudenza. Una analisi storica de...Maria Livia Rizzo
Corsi multimediali di tecniche di diagnosi e terapia prenatale ed ecografia ginecologica.
2010 – XXV anno
Alma Mater Studiorum - Università di Bologna
Clinica Ostetrica e Medicina dell’Età Prenatale
28 novembre 2010
Aspetti legali della stampa 3D: come tutelare una rivoluzione. Stampa 3D: sic...Maria Livia Rizzo
L’improvvisa accelerazione nel mercato della stampa 3D ha di fatto posto il mondo del diritto davanti ad alcune sfide giuridiche di non semplice soluzione. Il fenomeno del 3D printing sta infatti crescendo a dismisura, con il rischio che la rivoluzione dei makers sia ‘in-controllata’, con impatti negativi e rischi per tutta la filiera produttiva e per gli utenti finali. La stampa 3D ha messo in atto il c.d. processo di democratizzazione della manifatturizzazione, facendo entrare in crisi l’attuale sistema di proprietà intellettuale.
Complesse sono anche le implicazioni che tale tecnologia pone nel campo medico, in particolare in relazione alla qualità del prodotto finale e alla sicurezza del processo produttivo. Stampa 3D che comporta infatti rischi causati da dispositivi medici malfunzionanti o possibili danni alla salute derivanti dal processo di stampa o dall’utilizzo del prodotto stampato.
Oggi una soluzione definitiva non esiste. L’esempio di video, musica e libri dovrebbe aver fatto capire tutti che è inutile chiudere i file e adattare i contratti e le leggi vigenti. Innovare non significa adattare, significa capire la tecnologia e ripensare i modelli tecnologici e contrattuali.
Tips for better 3D printing for medical applicationsDesign World
One of the hottest applications for 3D printing / Additive Manufacturing is medical. Dental appliances, surgical models, prosthetic prototypes and some end use versions, skeletal support, and other applications are possible because of the unique capabilities of 3D printers. In this webinar we will hear from three vendors with applications in this field; their challenges, their successes, and what they’ve learned about working with 3D printers in this industry.
In this webinar you will learn:
The best medical applications for 3D printing today
Material considerations, including mechanical and thermal properties and biocompatibility.
Design tips
View the recording: http://www.designworldonline.com/upcoming-live-webinar-tips-for-better-3d-printing-for-medical-applications/
Il 5-6-7 marzo sono stato ospite di 3D Print Hub, il primo evento dedicato alla stampa 3D professionale, per parlare dei tanti aspetti legali della stampa 3D.
In particolare ho affrontato queste tematiche:
a) Stampa 3D e proprietà intellettuale: marchi, brevetti, copyright, concorrenza sleale e aspetti medicali;
b) Stampa 3D, marketplace e app: come vendere e tutelare file per la stampa 3D;
c) Stampa 3D, sicurezza sul lavoro e opere d'arte.
Di seguito le slides dei 3 interventi.
ll 14 aprile sono stato tra i relatori del Legal Tech Forum 2016, la prima conferenza italiana dedicata alle tecnologie legali, organizzata da Kopjra con il supporto di EIT Digital e TIM #Wcap Accelerator. La mia relazione ha approfondito la tematica del rapporto tra stampa 3D e il Codice della Proprietà Industriale.
A complete illustrated ppt on 3D printing technology. All the additive processes,Future and effects are well described with relevant diagram and images.Must download for attractive seminar presentation.3D Printing technology could revolutionize and re-shape the world. Advances in 3D printing technology can significantly change and improve the way we manufacture products and produce goods worldwide. If the last industrial revolution brought us mass production and the advent of economies of scale - the digital 3D printing revolution could bring mass manufacturing back a full circle - to an era of mass personalization, and a return to individual craftsmanship.
3D medtech printing under EU Medical Devices Directive and under future Medic...Erik Vollebregt
3D medtech printing conference maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
How FDA Regulates 3D Printed Medical DevicesEMMAIntl
3D printing has a multitude of applications in the medical device field. Right from the inception of the additive manufacturing technique, engineers have been working on how this technology can serve the health care industry. Additive manufacturing has the capability to manufacture devices that match the patient-specific anatomy using the medical images of the patients. FDA calls these devices patient-matched devices...
Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical devices. 3D printing medical devices allow manufacturers to easily create devices that function with a patient’s anatomy (also known as patient-specific devices). For this reason, 3D printed medical devices are especially popular for orthopedic, dental, and cranial implants and external prosthetics...
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Currently worth a few million dollars, the emerging organs-on-chips market has the potential to become a multi-billion dollar market.
Organs-on-chips: the promise of solving one of the pharmaceutical industry’s major hurdles
Bringing a new drug to market is one of the longest and most costly paths any industry has to walk. Companies start with several thousands of compounds that may have positive effects against a disease or a human condition. More than twelve years and several billion dollars later, if they’re lucky they managed to get one of these compounds onto the market. All the others failed at one stage or another during the drug development process – and the later the failure, the more expensive it is. Current methods – cell culture in petri dishes and animal testing among others – are not predictive enough. Around 90% of drugs that have been validated on these models then fail during clinical trials because of toxicity or lack of efficacy. The pharmaceutical industry therefore needs more predictive tools to make drug candidates fail earlier and cheaper. Other industries where toxicity testing is a major concern, such as cosmetics, agro-food and consumer goods, also need such solutions, in particular because animal testing is now banned for these industries in certain geographical areas. Several options have been envisioned, the most promising of which is certainly organs-on-chips. These combinations of micro-technology and biology reconstitute the physiological and mechanical functions of human organs under the form of micro-engineered devices lined with living cells. Precisely controlled fluid flows combined with mechanical cues and tissue-tissue interfaces enable dynamic models, much more relevant than conventional static cell cultures. As a sign of confidence in this technology, significant funding has been allocated to organs-on-chips developers: DARPA and the NIH respectively awarded $140M and $76M over 5-year periods to support developments. In parallel, technology developers have raised more than $80M since 2012 with investors. In Yole Développement’s report, all the key elements to understand the organs-on-chips landscape are detailed.
For more information, please visit our website: https://www.i-micronews.com/reports.html
Presentation: Regulation of personalised, including 3D printed, medical devicesTGA Australia
The status of making custom made devices exempt from registration is being looked at by TGA. But with the proliferation of 3D printing, we are getting more personalised medical devices. What is the right balance to enable innovation but having the right control to avoid major issues. This session is aimed at a more senior audience.
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Reprinting the law - legal aspects of 3D bioprinting - Ernst-Jan LouwersErnst-Jan Louwers
Presentation on bioprinting, protheses and personalized medicine at 3D Bioprinting Conference held at Maastricht on 19th June 2014. Legal aspects of 3D printing / additive manufacturing: also legally disruptive tech! Don't underestimate or miss disruptive developments like this! Be prepared and share best practices in everyone's best interest.
A small presentation on why Engineering Ethics is crucial in the Medical Device Industry. How a Product Design Engineer should make logical judgments while developing any medical devices.
Organ-on-chip Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...IMARC Group
The global organ-on-chip market size reached US$ 61.6 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 541.8 Million by 2032, exhibiting a growth rate (CAGR) of 26.5% during 2024-2032.
More Info:- https://www.imarcgroup.com/organ-on-chip-market
Guide on the use of Artificial Intelligence-based tools by lawyers and law fi...Massimo Talia
This guide aims to provide information on how lawyers will be able to use the opportunities provided by AI tools and how such tools could help the business processes of small firms. Its objective is to provide lawyers with some background to understand what they can and cannot realistically expect from these products. This guide aims to give a reference point for small law practices in the EU
against which they can evaluate those classes of AI applications that are probably the most relevant for them.
Defending Weapons Offence Charges: Role of Mississauga Criminal Defence LawyersHarpreetSaini48
Discover how Mississauga criminal defence lawyers defend clients facing weapon offence charges with expert legal guidance and courtroom representation.
To know more visit: https://www.saini-law.com/
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
Visit Now: https://www.tumblr.com/trademark-quick/751620857551634432/ensure-legal-protection-file-your-trademark-with?source=share
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
3D Printing ih healthcare: regulatory issues in the future of medicine
1. 3D PRINTING IN HEALTHCARE:
REGULATORY ISSUES IN THE
FUTURE OF MEDICINE
Avv. Maria Livia Rizzo, PhD
info@marialiviarizzo.com
marialiviarizzo.com
J R C R o u n d t a b l e o n a d d i t i v e m a n u f a c t u r i n g i n m e d i c a l d e v i c e s
J R C E u r o p e a n C o m m i s s i o n – I s p r a – N o v e m b e r 4 t h 2 0 1 5
2. Who I am
§ Lawyer
§ Law & Technology PhD
§ Research Fellow at CIRSFID – University of Bologna
§ Teaching Fellow at Forensic Medicine chair – Faculty of Law –
University of Bologna
§ Legal 3D Printing Co-Founder (legal3dprinting.it)
4. 3D PRINTER
§ Directive 2006/42/
EC of the European
Parliament and of the
Council of 17 May
2006
§ Product liability:
manufacturer
5. 3D PRINTING IN MEDICINE
Involvement of:
§ printer manufacturer
§ 3D model designer
§ surgeon
§ other healthcare professionals
§ hospital
§ ethics committee
§ insurance company
§ maker
6. 3D PRINTING IN MEDICINE
ANATOMICAL MODELS
MEDICAL DEVICES
BIOPRINTING
7. ANATOMICAL MODELS
§ diagnostic tools
§ surgical planning
§ medical training
- medical students
- surgical trainees
§ patient education
- to obtain informed
consent
§ medical research
8. ANATOMICAL MODELS
Legal issues
§ Liability for deviating from
an existing standard of
care?
§ Are supportive tools or
medical devices?
Regulation?
§ Informed consent:
§ Negotiating responsibility
§ Redirecting the decision
making authority back to the
patient
§ Decrease of medicolegal
claims
§ Defective tools:
§ Harms to patient
§ Lack of oversight of the
quality
9. MEDICAL DEVICES
§ anyone can print a MD
§ anyone can upload and
download a MD blueprint
§ counterfeit devices
§ unsafe devices
§ defective devices
§ errors in customization settings
§ toxic materials
§ harms to patient
§ implants
§ prosteheses
§ braces
§ guides and templates
Risks
10. MEDICAL DEVICES
Current EU regulation
§ Council Directive 93/42/EEC of 14 June 1993
Custom-made medical devices
§ Any device specifically made in accordance with a duly qualified
medical practitioner’s written prescription which gives, under his
responsibility, specific design characteristics and is intended for
the sole use of a particular patient.
§ A manufacturer of a custom-made medical device, who places
devices on the European market under his own name, must meet
the requirements of national legislation, which transposes the
Medical Devices Directive 93/42/EEC (MDD)
11. MEDICAL DEVICES
Who is the manufacturer?
§ Custom-made manufacturer –
“The natural or legal person who
undertakes the design of the
product and manufactures the
device to a predefined specification
(i.e. a prescription)” (EU Guidance Note
for Manufacturers of Custom-made Medical
Devices)
§ 3D model designer?
§ 3D printer producer?
§ health professional?
§ maker?
Low regulatory burden
§ Custom-made devices shall not
be CE marked (article 17 MDD /
article 12 AIMDD)
§ New Proposal MDR:
Manufacturers of CMMD must
ensure that their devices are
safe and perform as intended
§ suitable for low risk traditional
devices
§ unsuitable for high risk 3D
printed medical devices
12. MEDICAL DEVICES
3D printed MD will be still custom-made devices?
§ mass-produced devices which need to be adapted to meet
the specific requirements of any professional user and
devices which are mass-produced by means of industrial
manufacturing processes in accordance with the written
prescriptions of any authorised person shall not be
considered to be custom-made devices (New Proposal MDR)
§ Exclusion of individualized 3D printed medical devices from
the field of CMMD?
§ How is 3D printing process to be deemed?
14. MEDICAL DEVICES
FDA Additive Manufacturing Workshop (October 8-9 2014)
§ technical challenges and solutions to 3D printing
§ input regarding technical assessments related to AM
§ transparent process for future AM medical device submissions
§ future regulation of 3D printed medical devices
15. MEDICAL DEVICES
FDA Additive Manufacturing Workshop discussion topics:
§ Preprinting considerations:
– material chemistry
– physical properties
– recyclability
– part reproducibility
– process validation
§ Printing considerations:
– printing process
characterization
– software used in the process
– post-processing steps
– additional machining
§ Post printing considerations:
– cleaning/excess material
removal
– effect of complexity on
sterilization and
biocompatibility
– final device mechanics
– design envelope
– verification
16. MEDICAL DEVICES
FDA Additive Manufacturing Workshop: some findings:
§ encourage publication of failures, of situations where
inconsistency is found, and of defining such inconsistencies in
the context of the application
§ define additional requirements
§ establish additional standards or test methods to
demonstrate such consistency
§ Outstanding questions
§ FDA is actively seeking input from stakeholders in industry and
academia
but
18. BIOPRINTING
§ Risks
– biosafety
– malfunction or failure
– black market for
synthetic human body
parts
– bioterrorism
§ Current regulatory
framework
– stem cell research: for
research purposes
– organ transplantation:
for a transplantation
into a human body
§ specific regulation is
needed!