Several arms, one goal:
Your CE marking!
Your trusted EU Legal Manufacturer for Medical Devices
Outsource regulatory responsibility and fast-track your devices to the European market with CE-Med – ISO 13485 certified, MDR-compliant, and ready to scale with you.
- Full MDR & IVDR compliance – handled for you
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Your brand, your product – we stay invisible
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Complete supply chain & post-market oversight
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No EU office or QMS setup needed
- Launch in Europe up to 2 years faster
Expand into Europe Without Building Regulatory Infrastructure
CE-Med acts as your EU-based legal manufacturer – giving you immediate access to European markets without the overhead of establishing an EU entity, QMS, or in-house MDR expertise. We assume the full regulatory and legal responsibility, while you keep control of your brand, product, and IP. Focus on what you do best – we’ll handle the MDR.
Regulatory & Risk Management
CE-Med is your compliance gateway. We handle CE certification, post-market surveillance, and legal liability as your authorized EU Legal Manufacturer.
Market Acceleration
Get your medical devices to Europe faster – with our regulatory infrastructure, expert team, and partner network, we help you expand without delay.
MDR Compliance Is Complex. We Make It Simple.
Since the Medical Device Regulation (MDR) came into effect in 2021, the path to placing medical devices on the EU market has become significantly more complex, expensive, and resource-intensive. For many US-based companies, building the internal infrastructure to meet MDR requirements is not only costly – it delays market entry and slows down innovation. That’s where CE-Med comes in.
As your EU-based legal manufacturer, we take over the entire regulatory burden – including CE marking, technical documentation, post-market surveillance, and liability – so you can focus on what matters most: growing your business. Let us carry the weight of MDR compliance – and fast-track your access to Europe.
Without CE-MedWith CE-Med
CE-Med Is Part of the qtec Group – A Trusted Regulatory Powerhouse
CE-Med is a specialized unit within the qtec group, a leading European network of regulatory and quality experts for the MedTech industry.
With four dedicated business units, the qtec group covers the full lifecycle of medical devices – from development and clinical evaluation to regulatory strategy, CE-marking, and post-market surveillance.
This structure ensures that CE-Med, as your legal manufacturer, has immediate access to deep, cross-functional expertise – making your EU market entry smoother, faster, and fully compliant.
Let’s Simplify Your EU Market Access
We help US-based MedTech innovators enter the European market without the regulatory burden. Let’s explore how CE-Med can accelerate your EU expansion. Book a strategy call today!