At QNET, we provide manufacturers with regulatory representation and professional consultancy services. Whether you need an EU Authorized Representative (EAR), a UK Responsible Person (UKRP), a Swiss CH-REP, or a US Agent, or require specialist support with your technical documentation and Quality Management System (QMS), we are your partner for success in regulated markets.

We know your business depends on more than just fulfilling formal obligations. You need proactive guidance, technical expertise, and a partner you can trust to safeguard your compliance and market access.

More Than Representation: Full Service Regulatory Support

QNET combines regulatory representation with consultancy services that help you achieve and maintain compliance throughout the entire product lifecycle:

We act as your official EU Authorized Representative under MDR/IVDR, ensuring compliance, vigilance support, and direct communication with EU authorities.

We act as your official EU Authorized Representative under MDR/IVDR, ensuring compliance, vigilance support, and direct communication with EU authorities.

Authorized Representation

1.      EU Authorized Representative (EAR): Compliance with EU MDR/IVDR, liaison with authorities, post-market support.

2.      UK Responsible Person (UKRP): MHRA registration, UKCA documentation, regulatory communications.

3.      Swiss CH-REP: Swissmedic registration, MedDO/IvDO compliance, market surveillance support.

4.      US Agent Services: FDA Communications for Non-US Manufacturers.

QNET Ltd. (UK) acts as your Responsible Person for UKCA compliance, liaising with the MHRA and ensuring market access in the United Kingdom/NI.

Through our Swiss office, QNET CH-REP GmbH ensures compliance with Swissmedic requirements and provides your legal presence in Switzerland

Design, implementation, and maintenance of robust quality management systems.
Aligning with ISO 13485, QMSR, and international standards