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Medical Device Standards and Regulations
Medical Device Standards and Regulations
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ISO 13485 and ISO 14969 – Medical Devices QMS
ISO 13485 and ISO 14969 – Medical Devices Quality Management System
- Discussions:
- 101
- Messages:
- 614
Latest: ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3 Andy Nichols, Nov 1, 2023 -
ISO 14971 - Medical Devices Risk Management
ISO 14971 - Application of Risk Management to Medical Devices
- Discussions:
- 6
- Messages:
- 50
Latest: Certification to ISO 14971 ? Quality Manager Liz, Dec 8, 2017 -
IEC 60601 - Medical Electrical Equipment Safety
IEC 60601 - Medical Electrical Equipment Safety Standards Series
- Discussions:
- 21
- Messages:
- 71
Latest: Defining a lower ESD test limit for 60601 test Wins Letshawn, May 16, 2022 -
IEC 62304 - Medical Device Software
IEC 62304 - Medical Device Software - Software Life Cycle Processes
- Discussions:
- 7
- Messages:
- 33
Latest: IEC 62304 for developer tools that are packaged with final product. yodon, Aug 30, 2023 -
IEC 62366 - Medical Devices Usability Engineering
IEC 62366 - Application of Usability Engineering to Medical Devices
- Discussions:
- 2
- Messages:
- 8
Latest: Usability procedure yodon, Apr 3, 2018 -
Latest: CMDCAS addition to ISO 13485 OrangeIsEnergy, Aug 25, 2015
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Latest: New China RoHS Regulation [Effective on July 2016] QAengineer13, Apr 29, 2016
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EU Medical Device Regulations
European Union Medical Device Regulations
- Discussions:
- 39
- Messages:
- 154
Latest: EU MDR transitional period extension bozidar, Mar 6, 2023 -
Latest: Dropping MDSAP? Jennifer Kirley, Mar 13, 2023
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Other Medical Device Regulations World-Wide
Other Medical Device Regulations World-Wide
- Discussions:
- 16
- Messages:
- 44
Latest: Brazil / Japan: Essential Safety and Effectiveness Requirements MaxiFuer, Sep 15, 2019