Top 25 Medical Device Regulatory Consulting Firms 2025
Compare medical device consulting firms offering multi-country registration and authorized representative (AR) services for medical devices and IVDs.
What is Authorized Representative Services?
Medical device manufacturers expanding internationally need more than just consulting - they need authorized representatives (AR) who can legally represent them in foreign markets. An authorized representative takes on regulatory responsibility and liability on behalf of foreign manufacturers.
Key AR requirements by market: EU Authorized Representative (EC REP) required under MDR 2017/745 for non-EU manufacturers; Brazil Registration Holder (BRH) required by ANVISA for foreign companies; UK Responsible Person (UKRP) required post-Brexit for non-UK manufacturers; Korean License Holder (KLH) required by MFDS; and local agents required in China (NMPA), Japan (PMDA), and Taiwan (TFDA).
Medical device regulatory consulting typically costs $150-$500/hour, with 510(k) submissions ranging from $15,000-$80,000 and EU MDR CE marking from $20,000-$100,000+. This directory features 25 consulting firms across 42+ countries. Use the filters to find the right partner for your regulatory needs.
Showing 25 of 25 firms
AI-powered medical device regulatory consulting with offices in 15+ countries.
AI-powered regulatory platform supporting medical device registrations globally.
One of the largest global medical device regulatory consulting firms with 20+ offices worldwide.
European-based regulatory consulting with strong presence in EU, US, China, and emerging markets.
Global regulatory solutions company with expertise in medical devices, pharmaceuticals, and cosmetics.
Specialists in LATAM medical device markets with expertise in ANVISA, ANMAT, COFEPRIS and other national agencies.
Specialists in Asian medical device markets including Japan, China, South Korea, Taiwan, and Southeast Asia.
Global testing, certification, and notified body organization.
Leading U.
Full-service medical device development and regulatory consulting.
Regulatory consulting with local affiliates in China, Japan, Brazil, Mexico, and South Korea.
European regulatory consulting with expertise in EU, Japan, Korea, and emerging markets.
Full-service device development with biocompatibility testing labs.
Specialists in LATAM and emerging market medical device registration.
Comprehensive regulatory affairs, quality assurance, clinical trials, and laboratory testing services.
Customer-centric medical device regulatory consulting specializing in EU, USA, and UK regulations.
ISO 9001 certified consulting for medical devices, combination products, and diagnostics.
US-based consulting firm with offices in EU and Japan.
Established regulatory consulting since 1978.
European regulatory consulting with expertise in EU MDR/IVDR, clinical evaluations, and authorized representative services.
European regulatory consulting specializing in EU, UK, and Swiss markets.
European medical device and digital health regulatory consulting.
European authorized representative services for EU, UK, and Switzerland markets.
Understanding Authorized Representative Services
Advisory services that help you navigate regulatory requirements, prepare submissions, and develop market entry strategies.
- • Regulatory strategy development
- • Submission preparation (510k, CE, etc.)
- • Technical file creation
- • Clinical evaluation support
- • Quality system consulting
Legal representation in a market where you have no physical presence. The AR takes on regulatory responsibility and liability.
- • EU EC REP (MDR/IVDR)
- • UK Responsible Person (UKRP)
- • Brazil Registration Holder (BRH)
- • Korea License Holder (KLH)
- • China/Japan Local Agent