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Implementation of ISO 13485

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Guest user Created:   Apr 10, 2020 Last commented:   Apr 10, 2020

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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Step-by-step implementation for smaller companies.

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Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 10, 2020

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:

  • Design and development validation and verification according to ISO 13485  https://advisera.com/13485academy/blog/2019/02/14/design-and-development-validation-and-verification-according-to-iso-13485/ 

    For more information on managing the design and development of medical devices, please read the article at the following link:

  • How to manage design and development of medical devices according to ISO 13485:2016  https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/

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    Apr 10, 2020

    Apr 10, 2020