Services – Who We Support

Our services are aimed at companies that wish to distribute their medical devices on the European market in compliance with the law – in particular:

Medical device companies outside the EU looking to sell in Europe without building internal regulatory infrastructure.

Startups, OEMs, and contract manufacturers who want to accelerate EU market entry without taking on full MDR responsibilities.

As your EU Legal Manufacturer, we take over the entire regulatory workload – including CE marking, technical documentation, QMS, clinical data collection, and post-market surveillance. Our experienced team also supports your audits and serves as your point of contact for notified bodies.

Helping You Grow – Without Slowing Down

With CE-Med, you don’t just gain regulatory support – you gain a growth accelerator. We plug you into a trusted network of EU distributors, experts, and MedTech professionals.

Our seasoned team understands the challenges of scaling internationally and has successfully guided dozens of companies through the MDR jungle – quickly and compliantly.

You’ll enter the EU market without having to build or adapt your own QMS – and without wasting time on internal restructuring.

What makes CE-Med special?

  • Everything from a Single Source
    Complete solutions or modular services – flexibly tailored to your needs.
  • Personal & Connected
    Your dedicated contact person, backed by more than 100 experts.
  • Faster to Market
    With ISO 13485 certification and full-scope notified body integration.
  • Partnership for the Entire Lifecycle
    From market launch to long-term support – sustainable and reliable.

Start Strong – With CE-Med by Your Side

From day one, we support you through the entire lifecycle of your device – from technical documentation and regulatory strategy to communication with EU authorities and notified bodies.

Our Regulatory Affairs team serves as your strategic advisor, helping you interpret, implement, and fulfill MDR requirements in a smart, scalable way.

We don’t just tick boxes – we help you make better decisions that accelerate access and long-term success in Europe.

Who is named on the product when qtec CE-Med takes over the manufacturer role?

This is a question we are asked frequently when discussing the qtec CE-Med manufacturer takeover model – and it’s an important one.

The answer: When qtec CE-Med assumes the regulatory manufacturer role under the MDR, this does not mean that the product design, branding, or market appearance has to change. You just benefiting from full regulatory compliance and manufacturer responsibility under the MDR.

For our customers, this means:

  • full control over their brand
  • no confusion in the market
  • no changes for distributors or users

From the outside, the product clearly remains the customer’s product.

Brand & product appearance
The complete product design remains unchanged. The product continues to be placed on the market:

  • under the customer’s brand name
  • with the same visual identity
  • without any visible “rebranding” or loss of brand ownership

MDR-compliant labeling
From a regulatory perspective, it is only required that qtec CE-Med is:

  • listed discreetly and in small font
  • next to the manufacturer symbol
  • with name and address

Nothing more.

*This is a fictitious product example

When you contact CE-Med, you also receive contact with the

These steps entail our CE-Med service

1. GAP Analysis

Objective: Assessment of the conformity of the technical documentation with the requirements of the MDR (EU) 2017/745.

Services:

  • Review an evaluation of existing product documentation
  • Comparison with MDR requirements according to Annex II & III
  • Creation of a structured FAP analysis with recommended actions

Result: Clear overview of existing faps and necessary action for MDR compliance, as well as a sound basis for decision-making regarding the scope of subsequent implementation phase.

One-time expense

2. Implementation Phase

Objective: Preparation of the product’s technical documentation and integration into the certified quality management system of qtec CE-Med.

Services:

  • Preparation of the technical documentation according of the GAP analysis Phase 1, including
  • Developement documentation
  • Product description and specifications
  • Design and manufacturing information
  • Verification and validation documentation
  • Clinical evaluation
  • Biocompatibility assessment
  • Risk Management File
  • Labeling including UDI
  • General Safety and Performance Requirements (GSPR)
  • List of Applicable Standards
  • PMS (Post-Market Surveillance) Plans and Reports
  • Integration of the product into existing QMS processes of qtec CE-Med
  • Supplier Qualification and Approval, Including Audits and Creation of Quality Assurance Agreements (QAA)
  • Submission of the Technical Documentation to the Notified Body and Ongoing Communication

Result: The Product is fully integrated into the QMS of qtec CE-Med, the technical documentation has been prepared in compliance with the MDR, and has been submitted to the Notified Body for assessment (excluding Class I products). This phase concludes with the succesful certification by the Notified Body and CE marking of the product, enabling its release to market by qtec CE-Med.

One-time expense

3. Maintenance Phase

Objective: Ensuring continous MDR compliance throughout the entire product lifecycle.

Services:

  • Ongoing maintenance and updating of the technical documentation
  • Implementation of regulatory changes and new requirements
  • Execution and documentation of post-market activities (PMS/PMCF)
  • Evaluation of complaints/incidents
  • Literature research
  • Trend reporting
  • Preparation of PMS Report / PSUR, PMCF Report, and SSCP
  • Processing and assessment of market feedback (inquiries, complaints and (serious) incidents, including any resulting vigilance notifications to the competent authority)
  • Regular supplier evaluations
  • Product change management
  • Batch release for market placement, including the assessment of potential deviations and follow-up of CAPAs

Result: The product continuosly meets MDR requirements and is placed on the market long-term via qtec CE-Me, including ongoing post-market surveillance (PMS).

Ongoing expense

3 strong reasons why CE-Med is the right partner for you

Let’s Grow Together – Start Your EU Journey with qtec CE-Med

Our experts will help you design the ideal regulatory path for your company and your medical devices – fully compliant, business-ready, and built to scale.

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