Medical device CE marking

Quality system

Review quality documentation

Review of existing Quality Management System documentation to evaluate compliance with ISO 13485:2016.

In advance following documents must be provided by the manufacturer:

  • Quality Manual;
  • Standard Operating Procedures;
  • Checklists.

CEpartner4U will deliver a review report with conclusions and recommendations.


ISO Entry Pack

A systematic eight-step program provided via e-mail to set up a Quality Management System according to ISO 13485:2016.

This program requires active involvement of manufacturers personnel.

The steps are designed in a way that redundancy is avoided, and the amount of documentation is kept to a minimum.

At each step, you will receive instructions and ready-to-use templates for the quality handbook, Standard Operating Procedures, and other documentation.

This program includes our guidance while setting up regulatory agreements with suppliers, subcontractors, and distributors.

See Entrypackages


Quality Assurance implementation

Implement/adapt the manufacturer’s Quality Management System according to ISO 13485:2016, merging CEpartner4U’s templates and existing documentation/information that CEpartner4U will collect during phone calls and e-mail communication with the manufacturer or during on-site meetings. The existing Standard Operating Procedures and instructions will be included in the system.


  • Integration of existing quality documents in CEpartner4U’s format;
  • Business management analysis;
  • GAP analysis;
  • Recommendations for improvement;
  • Completion of missing procedures and documents;
  • Internal Audit.

CEpartner4U will use the existing documentation and our concept handbook, templates, procedures, and documents.