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About the Author: Uwe Meyer
Certification Manager, TUV Rheinland Medical
Uwe is responsible for management of the Medical Devices Testing business unit, bringing with him 20 years of experience in regulatory product testing and certification. He additionally participates in business development, technical/industry committees and supports accreditation programs, frequently speaking at conferences and webinars. |
Did you know that as of February 28, 2019, the new revision of the ISO 13485 (2016) has to be used? This also means that as of the same date, the transition must be complete from ISO 13485:2003 and the associated European Standard EN ISO13485: 2012.
The most important changes between the 2003 and 2016 version of the global standard for medical device quality management systems (QMS) are as follows:
- Incorporation of risk-based approaches beyond product realisation. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements
- Increased linkage with regulatory requirements, particularly for regulatory documentation
- Application to organisations throughout the lifecycle and supply chain for medical devices
- Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard
- Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay
- Emphasis on:
- Appropriate infrastructure, particularly for production of sterile medical devices
- Addition of requirements for validation of sterile barrier properties
- Complaint handling and reporting to regulatory authorities in accordance with regulatory requirements
- Consideration of post-market surveillance
- Additional requirements in design and development for:
- Usability
- Use of standards
- Verification and validation planning
- Design transfer and design records
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ISO 13485 deals with the whole lifecycle from design and development, through manufacture, transport and end of life. This new standard is also used for the Medical Device Single Audit Program (MDSAP), an international effort to reduce redundant audits of medical device manufacturers.
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