Top 24 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 24 consulting firms across 42+ countries. Use the filters to find the right partner for your regulatory needs.
Filters
Showing 24 of 24 firms
Pure Global
AI-powered medical device regulatory consulting with offices in 15+ countries.
Arazy Group
AI-powered regulatory platform supporting medical device registrations globally.
Emergo by UL
One of the largest global medical device regulatory consulting firms with 20+ offices worldwide.
Qserve Group
European-based regulatory consulting with strong presence in EU, US, China, and emerging markets.
Freyr Solutions
Global regulatory solutions company with expertise in medical devices, pharmaceuticals, and cosmetics.
MDRC Consulting
Specialists in LATAM medical device markets with expertise in ANVISA, ANMAT, COFEPRIS and other national agencies.
Pacific Bridge Medical
Specialists in Asian medical device markets including Japan, China, South Korea, Taiwan, and Southeast Asia.
MCRA
Leading U.
Veranex
Full-service medical device development and regulatory consulting.
Global Regulatory Partners (GRP)
Regulatory consulting with local affiliates in China, Japan, Brazil, Mexico, and South Korea.
Thema-Med
European regulatory consulting with expertise in EU, Japan, Korea, and emerging markets.
NAMSA
Full-service device development with biocompatibility testing labs.
MedReg International
Specialists in LATAM and emerging market medical device registration.
RQM+
Comprehensive regulatory affairs, quality assurance, clinical trials, and laboratory testing services.
I3CGlobal
Customer-centric medical device regulatory consulting specializing in EU, USA, and UK regulations.
EMMA International
ISO 9001 certified consulting for medical devices, combination products, and diagnostics.
Ken Block Consulting
US-based consulting firm with offices in EU and Japan.
Lachman Consultants
Established regulatory consulting since 1978.
QbD Group
European regulatory consulting with expertise in EU MDR/IVDR, clinical evaluations, and authorized representative services.
Casus Consulting
European regulatory consulting specializing in EU, UK, and Swiss markets.
Med-Di-Dia
European medical device and digital health regulatory consulting.
MDSS
European authorized representative services for EU, UK, and Switzerland markets.
Advena
Obelis Group
Understanding Authorized Representative Services
Regulatory Consulting
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
Authorized Representative
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