Our project leader will assess the completeness of the uploaded technical documentation regarding your product and conformity route and communicate you a time plan for your conformity assessment activities.
The technical experts with the relevant product expertise will be assigned to conduct your product review. The exact details will be based on your device classification and the appropriate conformity assessment route. Your technical experts will review the completeness and content of your documentation, including any additional documents or test results that provide evidence of conformity to the Regulation. They will ask rounds of questions where any gaps are identified. QMD Services has the right to discontinue the conformity assessment process after three rounds to check the product files, after that the process must be restarted. Your product(s) may be subject to additional assessment by specialist reviewers or consultation with a Competent Authority or the EU Commission.
A Quality Management System (QMS) Auditor will be assigned to assess your system to the QMS requirements of the Regulation through a two-stage audit: A system review (stage 1) will review the completeness of your QMS, and the QMS Audit Stage 2 will review the effective implementation and its compliance to the Regulation.
Note: For devices that are sterile or end-user sterilized, an additional assessment by our sterilization expert will be required
your project leader will conduct a review of the activities undertaken and, if satisfied that the requirements are met, will prepare a certification recommendation. They will then submit the information
for final QMD Services Final Review and Certification Decision.
Once the QMS and Product Assessments have confirmed compliance, the results will be checked by In the final review independent specialists will assess the results of QMS Audit and product reviews and, if satisfied that the requirements are met, will prepare a certification recommendation. They will then submit the information for the final QMD Services Certification Decision
Once approved, your certificates will be issued electronically to your organization