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I am in the process of applying for EC Mark certification. I have read the MDD 93/42/EEC directive and have read the EU's so called Blue Book (Guide to implementation. I am still unclear of how to produce a technical file and what the proper steps and format should be for a risk analysis.
A sample technical file for medical devices and any kind of guidance material for a risk analysis would be greatly appreciated.
Thank you in advance,
Pecks
A sample technical file for medical devices and any kind of guidance material for a risk analysis would be greatly appreciated.
Thank you in advance,
Pecks