Your fast track to compliant market access in the EU.
Bringing medical devices to the European market as a non-EU manufacturer can be complex, time-consuming, and resource-intensive. Under the EU Medical Device Regulation (MDR 2017/745) and IVDR (2017/746), appointing an EU Authorized Representative and a qualified PRRC is mandatory — but also an opportunity to get it right from the start.
We act as your dedicated EU Representative and PRRC, enabling you to enter the EU market quickly, safely, and with full regulatory confidence. We understand the realities of startups and SMEs — limited resources, tight timelines, and high stakes.
Our approach is hands-on, pragmatic, and tailored to your stage of growth. We don’t just ensure compliance, we help you avoid costly delays, reduce regulatory risk, and accelerate your path to commercialization. At the same time, we offer competitive and transparent pricing models, including flexible options and fixed-fee structures, enabling predictable budgeting and financial planning.
What We Do
We take full ownership of your EU regulatory representation — so you can focus on building your business:
- Act as your official EU Authorized Representative under MDR/IVDR
- Serve as your PRRC in accordance with Article 15
- Review and strengthen your technical documentation and compliance setup
- Support QMS alignment (ISO 13485) and regulatory readiness
- Guide and manage EUDAMED registration and EU market entry
- Act as your regulatory interface with authorities and notified bodies
- Support post-market surveillance, vigilance, and ongoing compliance
How We Work
We operate as a flexible and trusted extension of your team:
- Startup-friendly onboarding
- Fast, clear, and focused on what matters most
- Hands-on collaboration
- We work directly with your team, not above it
- Pragmatic guidance
- No over-engineering, only what creates real value
- Clear roadmap to compliance
- Step-by-step support toward EU market access
- Responsive and accessible support
- When you need us, not weeks later
- Scalable support model
- Growing with you from early stage to full commercialization
Who We Serve
We work with innovation-driven organizations operating in regulated environments:
- Medical device and diagnostics companies
- Pharmaceutical and biotechnology organizations
- Startups developing first-in-class products
- Scale-ups preparing for certification, reimbursement, and commercial scaling
- Established companies optimizing global R&D and production performance
We make EU compliance simple, predictable. and scalable – so you can focus on innovation, growth, anf getting your product to market.