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Re: Technical File for CE declaration - Template or Sample of required contents
I JUST completed our Technical File (TF) for a Class IIb product. As recommended, I divided it into two parts: A & B.
Because Part A needs to go to the Authorized Representative (AR) in Europe, it is all "hard copy", meaning no links to documents on our server. Since most of Part A informatiuon is "summary" type information, this worked well. The only big single item was a print-out (2 sided) of a 125 page user manual.
Part B was a bit different. Since this does NOT need to reside in the EU with the AR, it contains many links to live documents on our server. This avoided two major issues: printing out TONS of technical data, validations, etc., and (more significantly) eliminating the need to physically remove and replace pages when documents are revised. For example, documents reverenced in Part B would NOT contain the revision level, e.g. QM-12345-XXX, where XXX was the revision level reference. Then, I added the statement: "Current revisions of all documents in Part B of thei Technical File may are maaintained on the ABC Company controlled acccess server and may be accessed at: g\document\qualitysystem\technical file". In the electronic version of Part B, this is a live hyperlink. In the printed version, it is simply blue underlined text indicating the same structure.
Both Part A & B contain a table of contents in line with the NB-MED/2.5.1/Rec 5. I have attached these as references if anyone is interested.
If anyone has interest in a particular section, let me know (via email) and I'll provide a copy (redacted as needed).
I JUST completed our Technical File (TF) for a Class IIb product. As recommended, I divided it into two parts: A & B.
Because Part A needs to go to the Authorized Representative (AR) in Europe, it is all "hard copy", meaning no links to documents on our server. Since most of Part A informatiuon is "summary" type information, this worked well. The only big single item was a print-out (2 sided) of a 125 page user manual.
Part B was a bit different. Since this does NOT need to reside in the EU with the AR, it contains many links to live documents on our server. This avoided two major issues: printing out TONS of technical data, validations, etc., and (more significantly) eliminating the need to physically remove and replace pages when documents are revised. For example, documents reverenced in Part B would NOT contain the revision level, e.g. QM-12345-XXX, where XXX was the revision level reference. Then, I added the statement: "Current revisions of all documents in Part B of thei Technical File may are maaintained on the ABC Company controlled acccess server and may be accessed at: g\document\qualitysystem\technical file". In the electronic version of Part B, this is a live hyperlink. In the printed version, it is simply blue underlined text indicating the same structure.
Both Part A & B contain a table of contents in line with the NB-MED/2.5.1/Rec 5. I have attached these as references if anyone is interested.
If anyone has interest in a particular section, let me know (via email) and I'll provide a copy (redacted as needed).
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Thank you!