Implementation of ISO 13485
Hello! My company is a small contract engineering group that offers medical device development services. Since we are purely R&D (no manufacturing) does it make sense for us to implement ISO 13485 in your opinion? Thank you for your time.
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R&D of medical devices must be conducted under the requirements that are described in the clause 7.3 Design and development of standard ISO 13485:2016. Therefore, it makes sense for your company to implement ISO 13485. However, the scope of ISO 13485:2016 can be only providing the service. In that case, you won't have a description of the production and related documented procedures, rather a description of the Desing and development process and how you provide that service.
For more information on performing design and development validation and verification according to ISO 13485, please read the article at the following link:
For more information on managing the design and development of medical devices, please read the article at the following link:
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Apr 10, 2020