Effect of medical device class on ISO 13485 documentation
1. I would like to know how the class of a medical device affect in the documentation required to implement a quality management system according to ISO13485:2016.
2. I mean if we manufacturing the medical device of class IIa (specifically a gamma probe) what type of certifications should have it. (IEC60601 for electromedical equipment, electromagnetic compatibility, among other).
3. It's possible to know all documentation that is necessary for design and manufacturing gamma probes? thanks
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I would like to know how the class of a medical device affect in the documentation required to implement a quality management system according to ISO13485:2016.
The class of medical device does not affect the documentation required to implement a quality management system according to ISO13485:2016. The Claas of medical device only affects the technical documentation necessary to prove compliance with Medical device regulative.
For more information, please see the following articles:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
- How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/
I mean if we manufacturing the medical device of class IIa (specifically a gamma probe) what type of certifications should have it. (IEC60601 for electromedical equipment, electromagnetic compatibility, among other).
Your medical device must be certified by the notify body and get the CE mark. If it is equipment that is active (need electricity for the operating) then it has to have IEC 60601 certificate for electromagnetic compatibility. If you have some software that drives the device, that it should be validated according to the IEC 62304:2006 Medical device software — Software life cycle processes. Is there any other standard, it is hard to know because I do not have enough data.
It's possible to know all documentation that is necessary for design and manufacturing gamma probes? thanks
All documentation that is necessary for design and development of medical devices according to ISO 13485:2016 you can see in our ISO 13485:2016 Documentation toolkit on the following link:
https://advisera.com/13485academy/iso-13485-documentation-toolkit/
At the end of the page under the title "Toolkit Documents", you can search for Design and development. There you will find all the necessary documents.
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Jun 17, 2020