About QNET

At QNET, we believe representation is more than just ticking a regulatory box. It is a professional duty and a partnership built on trust. We act as an extension of your regulatory team, helping you navigate the complex requirements of the EU, UK, Switzerland, and the United States with clarity, precision, and care.

With more than two decades of experience in the medical technology sector, we understand that every manufacturer faces unique challenges. Our role is to simplify compliance, safeguard your market access, and give you the confidence to focus on what matters most: developing safe and effective products.

 

Who We Are

QNET is an independent consultancy and authorized representative service provider with offices across four major markets: the EU, UK, Switzerland, and the US. This presence allows us to support manufacturers globally while staying connected to local regulators and market dynamics.

We serve as your:

  • EU Authorized Representative (EU AR)
  • UK Responsible Person (UKRP)
  • Swiss Representative (CH-REP)
  • U.S. Agent

And beyond medical devices and IVDs, we also provide representation for Personal Protective Equipment (PPE), Machinery, and consumer products under the General Product Safety Regulation (GPSR).

 

Why Choose QNET

What makes QNET different is the level of expertise and accountability we bring to our role:

  • Our in-house Person Responsible for Regulatory Compliance (PRRC) is formally recognized under MDR/IVDR Article 15 and registered as an IRCA Principal Auditor. This isn’t symbolic — it means your files, declarations, and post-market activities are reviewed by a qualified regulatory professional.
  • Our international footprint allows us to provide seamless representation across jurisdictions — eliminating the hassle of managing multiple service providers.
  • With 20+ years of experience, we’ve built strong working relationships with manufacturers, notified bodies, and competent authorities.
  • We tailor our services to fit your business — whether you’re a start-up looking for end-to-end outsourcing or an established company seeking targeted support.

 

How We Support You

We don’t just provide a legal address — we provide full regulatory support across the product lifecycle:

  • Pre-Market: Technical documentation, classification advice, GMDN/EMDN codes, QMS implementation (ISO 13485, FDA QMSR).
  • Market Access: Authorized Representative, UKRP, CH-REP, US Agent, plus PPE, Machinery, and GPSR coverage.
  • Post-Market: PMS and vigilance systems, complaint handling, regulatory monitoring, and incident/crisis support.

 

Our Commitment

For QNET, compliance is not about paperwork — it’s about protecting patients, supporting innovation, and safeguarding your market access. We build long-term partnerships based on integrity, transparency, and a shared vision for safe and successful healthcare worldwide.

QNET: Your Compliance Partner, Today and Tomorrow.

 

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