Medical Devices Technical File
We mean, with «TECHNICAL FILE», all the necessary paperwork, information, objective evidence, able to prove the satisfaction of the regulatory and legislative requirements especially those essential of the european directives, for instance in the medical field, the ATTACHEMENT I of the Medical Devices Directive 93/42/CE, s.m.i. 2007/47/CE and in particular, according to the content of the ATTACHEMENT VII, comma 3, which requires that the technical file must include the following paperwork:
- a general description of the product, including the planned variants and the intended uses;
- the scheme of design and the manufacture methods, the schemes of the parts, the pieces, the circuitry, ecc.;
- the description and the necessary explanation to understand the above-mentioned schemes and the functionality of the product;
- the results of the risk analysis and a list of the rules under article 5, entirely or partially applied, and a description of the solutions adopted to meet the essentialof the above-mentioned directive, when requirements, in case of non-application of the rules under article 5;
- the results of design calculations, the controls carried out, etc.
- the pre-clinical assessment
- the clinical assessment of which is given in annex X;
- the labelling and the operating instructions;
MEQUIPE offers its 30-year experience of activity in the sector of product and system certification, especially in the medical field, for:
- WRITING COMPLETE TECHNICAL FILES
- ASSESSING TECHNICAL FILES, before presenting them to the notified body, or, in the name or on behalf of the notified body, in the capacity of THIRD PARTY ASSESSORS
- SUPPORTING THE MANUFACTURERS in the DISSOLUTION OF NON-COMPLIANCE detected by the Notified Body.
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