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:
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.
3 strong reasons why CE-Med is the right partner for you
We are in the same boat
We understand your challenges – because we’ve faced them ourselves.
As part of the MedTech industry, we know how confusing and overwhelming MDR requirements can feel.
That’s why CE-Med brings the expertise of over 100 regulatory specialists from the qtec group – experts who live and breathe EU compliance every day. With deep technical know-how and hands-on experience, we help you navigate uncertainty with clarity and confidence.
More Than a Business Decision
Choosing how to handle MDR is more than just a budget line – it’s a strategic decision that shapes your future in Europe.
Together, we assess your situation and help you choose the best path:
- Stay the legal manufacturer with our support
- Share certain responsibilities with CE-Med
- Or fully outsource the legal manufacturer role to us
We understand that this isn’t just about compliance – it’s about your vision, your team, and your product’s future. We’re here to support you on every level.
The qtec Group “Fleet Concept” – Four Units, One Mission
Behind qtec CE-Med stands the full strength of the qtec group – a specialized network of four expert units working together to bring your devices to market:
- qtec services: Regulatory Affairs and Quality Management experts for hands-on compliance support
- qtec EuRep: Your trusted EU Authorized Representative under MDR
- qtec CE-Med: Your Legal Manufacturer for fast and compliant EU market entry
- qtec Academy: Strategic training and knowledge expansion tailored to your team
This modular structure allows us to deliver exactly what your project needs – from single services to fully integrated support.
With qtec, you don’t just get a service provider – you gain access to an entire ecosystem built for MedTech success in Europe.
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.