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Guidance documents for CE marking

In order to save time for our customers, we have created series of Templates to help them to build their Technical Documentations.We give them free of charge.

These main documents are:

  • Checklist of the documents with shall be included in the full Technical Documentation
  • Checklist of the documents that we need to keep in our European office for allowing us to present to Competent Authorities upon request
  • General Safety and Performance REequirement list. The manufacturer has to answer with reference to standards and to the titles of their internal procedures
  • Template of Post-Market Surveillance Plan (PMS).
  • PMSR and PSUR templates
  • Symbols for multilingual labeling
  • Models of EU declarations of Conformity
  • ETC .. . .

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