At QNET, we provide manufacturers with trusted 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.

• Regulatory Representation
• Regulatory Consultancy

QNET combines regulatory representation with consultancy services that help you achve and maintain compliance throughout the entire product lifecycle: Full-Service Regulatory Support. 

With QNET as your regulatory partner, you benefit from multi-sector, multi-jurisdictional expertise. We safeguard your market access — across medical, industrial, and consumer products — so you can focus on innovation and growth.

We act as your official EU Authorized Representative in accordance with the EU MDR 2017/745 and EU IVDR 2017/746.

• Compliance oversight with MDR/IVDR requirements
• Liaison with European authorities and notified bodies
• Vigilance and post-market surveillance support
• EUDAMED representation

Entering or maintaining access to the UK market requires a designated UK Responsible Person (UKRP). QNET ensures compliance with the UK’s regulatory framework.

• MHRA registration and device submissions
• UKCA documentation and conformity support
• Regulatory communications with the MHRA
• Ongoing compliance monitoring for the UK market

Switzerland requires non-Swiss manufacturers to appoint a Swiss Authorized Representative (CH-REP) for medical devices, IVDs, and certain regulated products. We support you with:

• Swissmedic registration under MedDO and IvDO
• Compliance with Swiss regulations aligned to MDR/IVDR
• Market surveillance and vigilance coordination
• Swissdamed representation

For non-U.S. manufacturers marketing in the United States, the FDA requires a U.S. Agent. QNET provides:

• Acting as your official FDA communication channel
• Support with registration, device listing, and inspection readiness
• Timely handling of FDA inquiries and notices
• Smooth communication with U.S. authorities

We serve as your official representative for Personal Protective Equipment, e.g., Regulation (EU) 2016/425.

• Conformity assessment support and EU-type examination liaison
• Ongoing compliance with safety standards
• Vigilance and post-market monitoring for PPE

Under the General Product Safety Regulation (EU) 2023/988, non-EU manufacturers must appoint an authorized representative. QNET provides:

• Official EU representation for consumer products
• Documentation review and conformity monitoring
• Regulatory liaison with EU market surveillance authorities

Beyond acting as your regulatory representative, QNET provides a full suite of consultancy services to support your compliance journey. Our experts guide you from system implementation to market access and technical documentation, ensuring your business meets global regulatory requirements with confidence. With QNET, you gain a single partner for representation and consultancy. We combine regulatory expertise with hands-on operational support — helping you achieve compliance, maintain it, and expand globally.

QMS Implementation & Support

From ISO 13485 implementation to ongoing process optimization, we help you establish, maintain, and continually improve a compliant Quality Management System (QMS/QMSR).

• Tailored ISO 13485 implementation projects
• Integration with MDR/IVDR, UK MDR, Swiss MedDO/IvDO, and FDA QSR
• Training, internal audits, and process monitoring
• Long-term support for operational efficiency

Compliance doesn’t stop at placing your product on the market. We design and execute PMS plans that keep you aligned with regulatory obligations.

• PMS planning and execution
• Vigilance reporting and incident management
• Trend analysis and corrective action guidance
• Annual PMS reporting and updates for MDR/IVDR and UK MDR

We assess your existing documentation and systems against the latest regulatory requirements and international standards.

• Full gap analysis against MDR/IVDR, UK MDR, Swiss, and FDA frameworks
• Compliance audits in line with ISO 13485, ISO 19011, and ISO 17021
• Corrective and preventive action planning
• Practical guidance to close gaps efficiently

Our consultants guide you through the complexity of international regulatory pathways.

• Product classification (MDR/IVDR, UK MDR, Swiss MedDO/IvDO, FDA)
• Assignment of GMDN/EMDN codes
• Risk classification and assessment
• Strategic market-entry advice for the EU, UK, Switzerland, and the US

We help you construct or update your Technical Documentation to ensure it is complete, audit-ready, and aligned with the law.

• MDR Annex II & III and IVDR compliance
• Documentation structured to meet notified body and authority expectations
• Integration of harmonized standards and state-of-the-art requirements
• Audit-ready deliverables for CE, UKCA, and Swiss compliance