Recomendados
Recomendados
Mais conteúdo relacionado
Semelhante a ISO 14971 Risk Management for Medical Devices
Semelhante a ISO 14971 Risk Management for Medical Devices (20)
Último
Último (20)
ISO 14971 Risk Management for Medical Devices
- 1. ÁHÆTTUGREINING HUGBÚNAÐAR: ISO 14971 OG VÖRUÞRÓUNARFERLIÐ RÖGNVALDUR J. SÆMUNDSSON YFIRVERKFRÆÐINGUR - BIONIC VÖRUR 3/8/2012 RJS
- 2. VAXANDI HUGBÚNAÐARÞRÓUN Wood & Steel Mechanical solutions using advanced materials Bionics Braces made of steel and straps 3/8/2012 1960 RJS Today
- 3. MARGBREYTILEG HUGBÚNAÐARKERFI Verkfæri Tæknipallur Notendur 3/8/2012 RJS
- 4. HELSTU STAÐLAR EU US MDD FDA GMP Essential Quality System Requirements Regulation EU Harmonized Standards ISO 13485 Quality Management Systems IEC 60601-1 IEC 62304 IEC 62366 Electrical Safety Sofware Life-cycle Usability Engineering IEC 14971 Risk Management 3/8/2012 RJS
- 6. VÖRUÞRÓUNARFERLIÐ System level RA DFMECA PFMECA (draft) PFMECA 3/8/2012 RJS
- 7. VÖRUBREYTINGAR Product Announcement Test production Decision on Final audit meeting: product change Start a Risk Assessment Product Action project project in 1) Finish the change Meeting Notes items approval data base Form 10/11/12 checklist in according Meeting notes Form 496 the data base to RA 2) Close the project Approval by in the data base Technical lead/Platform manager Approval by: Director Engineering Director Product Management Director Manufacturing and Operations Director / Manager representing Purchasing 3/8/2012 RJS
- 8. VERKLAGSREGLA Severity (1-10) Occurance (1-10) Detectability (1-10) Risk Acceptance: RPN < 50 3/8/2012 RJS
- 9. VERKLAG - DFMECA Failure Effect(s): Current Design/Process Control: RPN (SxOxD) Item Item / process Potential Failure Local effect(s) : End user effect(s) : Potential Failure Cause(s) Failure prevention Failure Detection Ref Description and Mode: Occurance Detection # function: Severity 1) Ad hoc test. [Details of Ad hoc testing: Step 1) [RheoControl] Control variables through current controller code incorrectly set internally. to verify float to int casts] Inconsistant knee behavior, could 2) [Data Backup][HW]Memory [Sensors] [Actuator]Corrupted lead to user falling without warning corruption (internal/external). 1) Coding Standards. 2) Alpha test. (ref. to 1,6 Rheo Control Data handling values transfered between because of insufficient support 8 1 3 24 3) [RheoControl]Conversion issues 2) Code review Engineering Analysis of BPCB modules during stance phase or too much (float to int/int to float), e.g. output units Post Alpha Trial [2]) resistance during swing phase calculations and current controller [Details: Log and monitor control variables during level ground walking, stair descent and ramp descent/ascent.] Possible Failure Modes: Entry, Exit, Data input, Data output, Data handling, Calculations, Timing 3/8/2012 RJS
- 10. Á DÖFINNI • IEC 60601-1 3. útgáfa – Heildarrammi fyrir hugbúnaðarkerfi, þ.m.t. usability • Bætt umgjörð um áhættugreiningu – Komast út úr Excel – Samtenging við hugbúnaðarþróunartól • Heppilegri mælikvarðar notaðar við ákvörðun á RPN – Hættustig (Severity) – Líkur á hættuástandi (Probability of a hazardous situation) – Líkur á slysi (Probability of hazardous situation leading to harm) 3/8/2012 RJS