M
We a very small software house who have for many years sold a software toolkit for medical imaging, but do not sell final user products. Until recently, all the regulatory issues have been handled by our customers, on the basis that however good (perfect?) our tookit is, the responsibility for the integration and testing of the final product is solely theirs. However, in the last few months, we have been receiving requests for documentation to show that our toolkit is a fit and proper component in their products, and I need to know how to proceed. My current guesses (based on reading, but no expertise) are that:
Dave
- We need to claim conformance to EN 62304
- We should have suitable internal processes to back up that claim
- EN 62304 does not require external auditing
- We don't require a formal quality system (and the army of staff to write the paperwork!) for EN 62304 (this is based on the afct that EN 62304 has a checklist specifically for companies without a formal ISO 9000 derived Quality system!)
- Am I right on all the above, or have I been too optimistic?
- Will I need to take on multiple other people just to write bits of paper?
- How should I get started on this road?
Dave
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