Generating quality documentation

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:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• 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/

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:

• How to manage the Quality Manual according to ISO 13485:2016 requirements https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/
• ISO 13485: How to write a short quality manual https://advisera.com/13485academy/knowledgebase/iso-13485-how-to-write-a-short-quality-manual/