Partner with us to streamline your regulatory journey and focus on what matters most—bringing innovative medical solutions to the people who need them.
Send an email to info@rqmis.com or click the link below to learn more.
In today’s interconnected world, successfully entering and sustaining a presence in global markets requires medical device companies to meet complex regulatory requirements. At RQMIS, we simplify this journey by offering expert representation services across the United States, European Union (EU), and United Kingdom (UK).
U.S. Agent Services (FDA Official Correspondent)
For companies without a physical presence in the U.S., appointing an FDA-registered U.S. Agent is not just a regulatory formality—it’s a key step for entering the U.S. market. RQMIS provides reliable U.S. Agent services, ensuring compliance with FDA requirements while serving as your trusted liaison with regulatory authorities. This role is especially critical for handling FDA communications, device registrations, and submissions.
EU Authorized Representative (EUAR)
The EU mandates that non-EU manufacturers designate a single Authorized Representative to facilitate compliance with its stringent regulatory framework. RQMIS serves as your EUAR, offering:
- Representation with a registered address in the EU.
- Review and maintenance of technical documentation for inspections.
- Assistance with device submissions and notifications to Competent Authorities.
- Incident reporting consultancy and regulatory updates compliance.
- Support for regulatory and quality teams on European regulations.
These services ensure your devices meet the standards for market entry and sustain long-term compliance.
UK Responsible Person (UKRP)
Post-Brexit, the UK introduced the requirement for non-UK manufacturers to appoint a UK Responsible Person (UKRP). Acting as your UKRP, RQMIS manages your compliance needs under UK regulations, serving as the primary contact for regulatory authorities and ensuring a smooth path for market access.
Why Partner with RQMIS
Navigating regulatory landscapes across multiple regions can be daunting. With extensive expertise in global regulatory compliance, RQMIS provides end-to-end support to help your medical devices meet all necessary requirements. From representation to strategic consulting, we’re committed to facilitating your success in the U.S., EU, and UK markets.