CE/QMS Entry Packages©

EU MDD Entry-package

a simplified, electronic seven-step system to implement the requirements of the Medical Devices Directive including how to:

  • Establish accurate risk classification and how to organize devices groups to minimize quantity of technical files
  • Use of existing documentation and gap analysis
  • Risk analysis /  usability procedure conform EN ISO 14971:2012 and EN 62366:2008
  • Essential requirements checklist
  • Templates of required documentation

Review Technical File

Review of existing technical file documents, risk classification and conformity assessment of your product to validate their compliance with applicable Annex of the Medical Device Directive 93/42/EEC, as amended.

Time:
Implementation period, 2 weeks after receipt of Technical File documents

Document:
Review report with conclusions and recommendations

Please note: In case non-compliances with the Directive are found, CEpartner4U may assist the manufacturer in completing the Technical File at an additional charge, which will depend on the extent of the extra work. After having finished the Technical File’s audit CEpartner4U will, If applicable, communicate the extent of the extra work and a proposed fee.

 

Entry Package

If technical documentation does not exist or is not available (and technical file review is not possible).

Technical file assistance, a systematic seven step system delivered by e-mail or fax to complete the technical documentation as required in the Medical Device Directive

Contents:
7 Steps, mailed in such sequence that repeat is eliminated and documentation is kept to a minimum

Unlimited support via phone, fax or e-mail; for one product-group

Documents:
For each-step, examples of written procedures and technical documentation

Time
Implementation period, 2 – 4 months