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UK Responsible Person For Medical Devices

Streamlined Medical Device Regulatory Support

We are a team of dedicated medical device regulatory professionals and national representatives for seven countries. With extensive experience in medical device regulation, we go beyond clerical work as UK Responsible Persons (UKRPs) from our UK headquarters. Since 1999, we have been delivering a comprehensive range of services to medical device manufacturers worldwide, ensuring their success in the industry.

UKRP Services:

  1. UKRP Services: Our expertise extends to UKCA Technical Documentation, Clinical Evaluation, Biological Evaluation, Certification Body coordination, ISO 13485 Implementation support, and MHRA registration services. We provide end-to-end support for manufacturers beyond the scope of UKRP obligations.

  2. Regulatory Consulting: Our team comprises experienced consultants, regulatory experts, and auditors who possess in-depth knowledge and understanding of complex device regulations. We offer expert opinions, valuable advice, and guidance tailored to your specific regulatory needs.

  3. Full-Scale Certification and Compliance Support: Beyond UKRP services, we offer a comprehensive range of A to Z services for certification and regulatory compliances. From initial assessment to audits, we provide the guidance and support necessary to achieve and maintain compliance in various global markets.

  4. Client-Focused Approach: We pride ourselves on maintaining strong and friendly business relationships with our clients. We offer multiple payment options to accommodate diverse international transactions, ensuring a seamless and convenient experience.

  5. Complimentary GMDN Code Identification: As part of our commitment to assisting manufacturers, we provide free identification of appropriate Global Medical Device Nomenclature (GMDN) codes, facilitating accurate device classification and conformity.

  6. Associated Laboratories: We have established partnerships with reputable laboratories specializing in biocompatibility and safety testing across multiple countries. This enables us to provide streamlined access to essential testing services, ensuring compliance with regulatory requirements.

Partner with us and benefit from our unwavering dedication, vast expertise, and proven track record in the medical device industry. We are committed to helping you navigate complex regulatory landscapes, achieve compliance, and drive the success of your medical devices in global markets.

Looking for GMDN codes support? Take a look and contact us!

UK Responsible Person For Medical Devices
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