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Generating quality documentation

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Guest user Created:   Sep 09, 2020 Last commented:   Sep 11, 2020

Generating quality documentation

We are a startup and are all R&D personnel.

1. Can I generate quality documentation and have at least two other people in the R&D group review and approve them?

2. Can Quality Manual be revised as often as needed to reflect our developing stages?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Sep 11, 2020
1. Can I generate quality documentation and have at least two other people in the R&D group review and approve them?

Yes, you can generate quality documentation on your situation. Design and development for medical devices have to deal with relevant regulations, product safety, and risk controls on product defects in addition to the usual application requirements, specification requirements, and end-customer needs. 

Here is the list of mandatory documents from ISO 13485 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

Of course, if you do not have certain processes (for example sterilization, or your product is not software), then there is no need to prepare and have those documents in your quality management system. 

The following articles can be helpful:

2. Can Quality Manual be revised as often as needed to reflect our developing stages?

Yes, the Quality manual can be revised as often as you need. The quality manual must be the reflection of your current state.

For more information, please see the following links:

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Sep 09, 2020

Sep 11, 2020