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.
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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
Consulting firms and authorized representatives, compared
Medical device manufacturers expanding internationally need more than consulting: most major markets require an authorized representative — a local entity that legally represents the foreign manufacturer and takes on regulatory responsibility and liability. The EU requires an EC REP under MDR 2017/745, Brazil a Registration Holder (BRH) with ANVISA, the UK a Responsible Person (UKRP) post-Brexit, and China, Japan, South Korea, and Taiwan require local agents or license holders.
This directory lists 24 consulting firms across 42+ countries. Use the filters to narrow by region, country, AR services, and transparent flat-fee pricing.
- What is the difference between regulatory consulting and authorized representative services?
- Regulatory consulting is advisory: preparing submissions such as 510(k) or CE technical files, developing strategy, and navigating requirements. Authorized representative services mean the firm legally represents you in a market where you have no presence, taking on regulatory responsibility and liability. Many manufacturers need both — consulting for initial registration and ongoing AR services for market maintenance.
- Which countries require a local representative for medical device registration?
- Key markets include the EU (EC REP for non-EU manufacturers), UK (UKRP), Brazil (BRH), Japan (DMAH/MAH), South Korea (Korean License Holder), China (local agent), Taiwan, Saudi Arabia, UAE, and most LATAM countries. Requirements vary: some require a legal entity, others accept appointed representatives.
- How much do medical device regulatory consulting services cost?
- Consulting typically costs $150–$500 per hour. FDA 510(k) submissions range from about $15,000–$80,000, EU MDR CE marking from $20,000–$100,000+, and authorized representative services from $2,000–$15,000 per year depending on market and device risk class. Always request detailed quotes — complexity and device class significantly affect pricing.
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