Is ISO 13485 for fertility company?
I manage a Research and Development lab for a women’s fertility company. We develop kits and assays for genetic testing but we do not manufacture anything in our lab specifically. Would ISO 13485 be the right option for us?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, ISO 13485 will be the right option since it includes Research and development part. There are some specialties within ISO 13485 that are requested for the design and development of in vitro medical devices that are not covered in other standards or norms. We have developed Desing and development toolkit that is in compliance with both ISO 13485 and EU MDR 2017/745.
Preview of the some of documents you can find on the following links:
- Procedure for Design and Development https://advisera.com/13485academy/documentation/procedure-for-design-and-development-iso-13485-2016/
- Design and Development File https://advisera.com/13485academy/documentation/design-and-development-file-iso-13485-2016/
- Project Plan and Review https://advisera.com/13485academy/documentation/project-plan-and-review-iso-13485-2016/
- Change Review Record https://advisera.com/13485academy/documentation/change-review-record-iso-13485-2016/
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Mar 16, 2023