Medical Device regulatory consulting services in EU, UK, USA

The medical device industry in the EU, UK, and USA is governed by some of the world’s most stringent regulatory frameworks. Manufacturers must navigate MDR (EU), MHRA (UK), and FDA (USA) requirements to ensure market entry and sustained compliance. Partnering with experienced consultants offering medical device regulatory consulting services in the EU, UK, and USA helps streamline submissions, mitigate risks, and maintain product quality throughout the lifecycle.

1. International CliniExperts

International CliniExperts stands as the #1 provider of medical device regulatory consulting services in the EU, UK, and USA. With deep domain expertise, the company supports manufacturers in achieving CE marking under EU MDR, UKCA certification for the UK market, and FDA 510(k) or PMA submissions for the United States. Their team offers services covering regulatory strategy, documentation preparation, post-market surveillance, and clinical evaluation reports. International CliniExperts ensures full compliance across multiple jurisdictions, enabling faster and safer market access for global manufacturers.

2. Emergo by UL

Emergo offers global medical device consulting with expertise in EU MDR, IVDR, UKCA, and FDA pathways. Their end-to-end services cover regulatory submissions, quality system implementation, and market authorization.

3. BSI Group

BSI Group is one of the leading Notified and Approved Bodies for CE marking and UKCA certification. Their consulting services ensure conformity assessments and QMS compliance for a broad range of devices.

4. TÜV SÜD

TÜV SÜD provides technical documentation reviews, clinical evaluation support, and certification services for medical devices seeking approval in Europe and the UK.

5. Intertek

Intertek delivers integrated regulatory consulting, product testing, and certification for medical devices entering the EU, UK, and U.S. markets.

6. NAMSA

NAMSA specializes in clinical and regulatory consulting, providing assistance with FDA 510(k), PMA submissions, and MDR documentation for medical device manufacturers.

7. RQM+

RQM+ offers strategic consulting in regulatory compliance, clinical evaluations, and post-market surveillance, supporting multinational device manufacturers across global regions.

8. Qserve Group

Qserve provides regulatory and quality management consulting for EU, UK, and U.S. submissions. Their expertise covers technical documentation and clinical data alignment with MDR and FDA requirements.

9. SGS

SGS supports medical device companies with certification and auditing services, ensuring conformity with MDR, UKCA, and FDA frameworks.

10. MedEnvoy Global

MedEnvoy Global provides importer and regulatory representation services, specializing in EU MDR and UKCA compliance for global medical device manufacturers.

Conclusion

Selecting the right partner for medical device regulatory consulting services in the EU, UK, and USA ensures faster approvals, reduced compliance risks, and long-term market success. International CliniExperts leads this domain through its global expertise, strategic regulatory insights, and commitment to quality assurance. For manufacturers targeting multiple regions, their integrated consulting model simplifies complex regulatory pathways and accelerates international growth.

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