CMC MEDICAL DEVICES & DRUGS

Name

CMC MEDICAL DEVICES & DRUGS

Legal name

CMC Medical Devices & Drugs SL

Website

https://cmcmedicaldevices.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

SIC

Services-Health Services (8000)

akta.pro primary industry

CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC) (HLAGAKAB)

Keywords

• Regulatory affairs consulting
• Medical device compliance
• Authorized representative services
• EU MDR consulting
• IVDR compliance services

Headquarters

HQ city

Málaga

HQ country

Spain

HQ region

Europe

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Regulatory Consulting and Representation Services: CMC Medical Devices & Drugs generates revenue through professional consulting fees charged for regulatory affairs services, authorized representative mandates, and compliance support across multiple international markets. Services include EU REP, UK REP, CH REP, TGA Sponsor, FDA Agent, China REP, FSC issuance, CRO services, and specialized consulting for MDR, IVDR, ISO 13485, manufacturing licenses, import licenses, EUDAMED and SWISSDAMED registration.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

CMC Medical Devices & Drugs is a regulatory consulting firm that provides authorized representative services and regulatory affairs support for medical device and in vitro diagnostic (IVD) manufacturers seeking market access across international jurisdictions. It operates a multi-country representative network spanning the EU, UK, Switzerland, Australia, USA, and China, alongside consulting engagements for MDR/IVDR compliance, ISO 13485 quality systems, EUDAMED/SWISSDAMED registration, Free Sale Certificates, CRO clinical research, and global registration.

Product overview

CMC Medical Devices & Drugs is a global regulatory consulting firm offering a comprehensive portfolio of services for medical device and in vitro diagnostic (IVD) manufacturers seeking international market access. The company operates through its global authorized representative network, providing EU REP, UK REP, Swiss REP, TGA Sponsor, FDA Agent, and China REP services across major regulatory jurisdictions. Its consulting portfolio includes MDR and IVDR compliance consulting, ISO 13485 quality management system consulting, EUDAMED and SWISSDAMED registration services, Free Sale Certificate (FSC) procurement, and CRO clinical research services. Additional services cover global registration across Southeast Asia, South America, Middle East, and Asia-Pacific regions, along with legal importer services, manufacturing/import license consulting, and specialized representation for cosmetics and PPE products. The company also provides GPSR compliance consulting and serves as Legal Representative for clinical investigations.

Differentiator

Problem solved

Functional benefit

Products and services

• EU REP (European Authorized Representative) Authorized representative service for manufacturers placing medical devices on the EU market without a local legal entity. Handles regulatory compliance, technical documentation, and communication with competent authorities.
• UK REP (UK Authorized Representative) Authorized representative service for medical device market access in the United Kingdom, ensuring compliance with UK MDR requirements.
• CH REP (Swiss Authorized Representative) Authorized representative service for Switzerland, managing Swissmedic registrations and swissdamed compliance for medical devices and IVDs.
• TGA Sponsor (Australia) Sponsor services for device registration with the Australian Therapeutic Goods Administration (TGA).
• FDA Agent (USA) FDA agent services for US market access, supporting 510(k), PMA, and other FDA submission processes.
• China REP Authorized representative service for medical device registration and market access in China through NMPA regulatory pathway.
• MDR Consulting Regulatory consulting for compliance with EU Medical Device Regulation (MDR 2017/745), including technical documentation, clinical evaluations, and CE mark approvals for Class I, IIa, IIb, and III devices.
• IVDR Consulting Regulatory consulting for compliance with EU In Vitro Diagnostic Regulation (IVDR 2017/746), covering classification, performance evaluation, and IVD registration.
• ISO 13485 Consulting Quality management system consulting for ISO 13485:2016 certification and compliance for medical device manufacturers.
• EUDAMED Registration Registration services for the EUDAMED database, covering device registration, UDI assignment, and EUDAMED module compliance.
• SWISSDAMED Registration Registration and compliance services for the swissdamed database, including UDI device module registration for Swiss market access.
• Free Sale Certificates (FSC) Obtaining Free Sale Certificates from key global jurisdictions to facilitate international device exports and market access.
• CRO Services Clinical Research Organization services for medical device clinical investigations, including study design, monitoring, and regulatory submissions.
• Legal Importer Services Legal importer services for medical devices entering the EU market, ensuring compliance with importer obligations under MDR/IVDR.
• Global Registration Services Comprehensive global market registration services covering regulatory submissions in Southeast Asia (Thailand, Vietnam, Indonesia, Hong Kong, Malaysia, Philippines), South America (Peru, Brazil, Mexico, Colombia), Saudi Arabia, Korea, India, and other regions.
• Cosmetics Representation Regulatory representation and compliance services for cosmetic products in regulated markets.
• PPE Representation Regulatory representation and compliance services for Personal Protective Equipment (PPE) products.

Quantifiable outcome

• Serving manufacturers in more than 70 countries
• +1 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Registrar CorpflagshipStrategic or Co-development Partner · 30 October 2025On October 30, 2025, CMC Medical Devices joined Registrar Corp, a worldwide leader in regulatory compliance and technology solutions backed by Paine Schwartz Partners. This strategic acquisition integrates CMC's technical and clinical capabilities with Registrar Corp's advanced technology and international presence. The combined entity provides coverage to over 75% of the global medical device market, offering manufacturers a unified partner for U.S., EU, and other international regulatory compliance.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• RegDesk: A regulatory intelligence and submission management platform targeting medical device and IVD manufacturers. Competes for the same regulatory affairs budget as CMC, with overlapping coverage of multi-jurisdictional device registration workflows.
• Freyr Solutions: A global regulatory services and solutions provider for life sciences companies, including medical devices and IVDs. Offers similar multi-jurisdictional regulatory support, including EU/UK/RoW authorized representation and submissions management.
• Emergo by UL: The largest and most established direct competitor, offering global authorized representative services (EU, UK, Switzerland, Australia, etc.) and MDR/IVDR consulting for medical device and IVD manufacturers. Operates as part of UL Solutions, providing a near-identical service portfolio to CMC across overlapping jurisdictions.
• NAMSA: The world's largest medical device-focused CRO, offering regulatory consulting, clinical research, and quality systems support. Comparable to CMC's CRO services arm and increasingly to its broader regulatory consulting portfolio.
• Pure Global: A medical device regulatory consulting firm that helps manufacturers achieve market access across multiple jurisdictions (FDA, EU MDR, Health Canada, etc.). Directly comparable to CMC in offering global registration and authorized representative services.
• Mantra Systems: A medical device quality and regulatory consulting firm (formerly Maetrics), specializing in EU MDR/IVDR compliance, ISO 13485, and authorized representative services. Direct competitor in European-focused medical device regulatory consulting.
• Rimsys: A SaaS regulatory affairs management platform purpose-built for medical device companies. While software-led rather than services-led, Rimsys competes for the same medical device regulatory budget and increasingly bundles submission and market authorization workflow support.

Broad incumbents

• IQVIA: The largest global CRO and life sciences services firm, with regulatory affairs capabilities spanning medical devices and pharma. Competes with CMC for enterprise medical device manufacturer relationships, particularly those seeking integrated regulatory, clinical, and commercial services.
• Parexel: A major global CRO with extensive medical device and pharma regulatory consulting capabilities. While broader in scope, Parexel competes with CMC for medical device manufacturers seeking global regulatory compliance and clinical investigation support.
• ICON plc: One of the world's largest CROs, providing global regulatory affairs, clinical research, and consulting services for medical devices and pharma. Overlaps with CMC's CRO offering and broader regulatory services, though medical devices are only a slice of ICON's portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/cmcecrep
• Facebookfacebook.com/qmscicmc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CMC MEDICAL DEVICES & DRUGS