From First Contact to CE Certificate
Get a CE mark for your device through conformity assessment with QMD Services. Our process is lean and clearly structured, from the first contact to certification.
The Process
Ten Steps to Certification
Prepare for certification
Put a quality management system in place that meets the MDR or IVDR. How long this takes depends on your preparation and the quality of your documentation; gaps can lead to extra assessment cycles.
Pre-application
Check our designation in NANDO and complete the online form. We carry out a free feasibility check and give you an indicative budget. You then share more details on your company and devices so we can prepare a formal quote.
Application
The formal application starts when the service contract is signed. A dedicated Project Leader is assigned, and we review the structure of your QMS and supporting documents.
Completeness check and project planning
You submit your technical documentation for an initial review. Once it is complete, we confirm the assessment programme, sampling plan, audit schedule and project start date.
Start of conformity assessment
Projects begin on a first-come, first-served basis, following the timelines agreed together during planning.
Technical documentation assessment
Expert reviewers evaluate your device against regulatory requirements, including test reports and clinical data. There are at most three rounds of questions and answers. Some device types also need review by EU Reference Laboratories.
QMS audit
A two-stage audit: Stage 1 is a remote documentation review, and Stage 2 takes place on site to confirm the system is implemented and working. Any nonconformities must be closed before certification.
Final review and decision
Our technical experts prepare a certification recommendation, which an independent review team checks for consistency and regulatory compliance.
Certificate issued
After a positive decision, your certificate is issued electronically.
Maintaining your CE certification
During surveillance, technical documentation continues to be sampled throughout the certificate's validity. Certificates are valid for up to five years and must be renewed before they expire.
Begin Your Journey to Certification
Connect with our team today and take the first step.
