TNMC & TNMC Medical Devices UK

Name

TNMC & TNMC Medical Devices UK

Legal name

TNMC

Website

https://tnmc.biz

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Compliance Consulting

NAICS

Other Scientific and Technical Consulting Services (541690)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industry

Medical Device Regulators (HLAJADAC)

Keywords

• Medical device regulatory consulting
• EU authorized representative services
• CE marking consulting
• Sterilization validation services
• ISO certification consulting

Headquarters

HQ city

Johannesburg

HQ country

South Africa

HQ region

Africa

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Regulatory Consulting Services: Professional consulting services for medical device regulatory compliance including CE-Marking, FDA approvals, and regulatory submissions for manufacturers outside Europe.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

TNMC is a regulatory consulting firm that helps non-European medical device manufacturers obtain and maintain CE-Marking and FDA approval, and acts as their EU Authorized Representative through offices in the UK and Croatia. It also designs and validates Clean Air Rooms per ISO 14644-1, performs sterilization validation for EtO, Gamma, and Heat processes, and assists companies with ISO 9001, 14001, 17025, HACCP, and ISO 22000 certifications.

Product overview

TNMC is a regulatory consulting firm offering a comprehensive suite of services for medical device manufacturers. The company provides EU Authorized Representative services through its UK and Croatia offices (TNMC Medical Devices UK and TNMC Devices Croatia), enabling non-EU manufacturers to place medical devices bearing the CE-Mark in the European market. Core offerings include Medical Device Regulatory Compliance Consulting (CE-Marking and FDA approvals), Sterilization Validation (EtO, Gamma, Heat), Clean Air Rooms design and validation per ISO 14644-1, and Food Safety Consulting (ISO 22000, HACCP). The portfolio also includes Laboratory Certification Consulting (GLP, GCP, ISO 17025) and ISO Management System Certification Consulting (ISO 9001, ISO 14001). Founded by industry veterans André and Ilse, the company has assisted over 90 medical device manufacturers in obtaining CE-Mark and/or FDA approval.

Differentiator

Problem solved

Functional benefit

Products and services

• EU Authorized Representative Services EU Authorized Representative services for non-European medical device manufacturers required to appoint a European-based representative to legally place CE-Marked devices on the European market, including acting as the primary contact with national Competent Authorities, device registration, Technical File maintenance, incident reporting, and representation before the European Commission.
• TNMC Medical Devices UK (UK Authorized Representative Office) UK-based office serving as an official EU Authorized Representative for medical device manufacturers worldwide, handling CE-Mark compliance, liaison with national Competent Authorities, and ongoing regulatory representation.
• TNMC Devices Croatia (Croatia Authorized Representative Office) Croatia-based office serving as an official EU Authorized Representative for medical device manufacturers worldwide, handling CE-Mark compliance, liaison with national Competent Authorities, and ongoing regulatory representation.
• Clean Air Room Design, Construction and Validation Design, construction, modification, and validation of Clean Air Rooms for medical device, pharmaceutical, and other manufacturers, delivered in accordance with ISO 14644-1 standards.
• Medical Device Regulatory Compliance Consulting Consulting engagements that assist medical device manufacturers in obtaining CE-Mark per Medical Device Directive 93/42/EEC and FDA approval, including clinical evaluation work under ISO 14155 and MEDEV 2.7.1, intended for non-European and U.S.-targeting medical device companies.
• Sterilization Validation Services Validation services for EtO (ethylene oxide), Gamma radiation, and Heat sterilization processes for medical devices, performed by TNMC's sterilization validation experts.
• Food Safety Consulting Consulting services for food safety management system certification under ISO 22000 and HACCP, targeted at food producers and processors.
• Laboratory Certification Consulting (GLP, GCP, ISO 17025) Assistance for laboratories in achieving Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance and obtaining ISO 17025 certification.
• ISO Management System Certification Consulting Consulting services that help organizations obtain ISO 9001 (Quality), ISO 14001 (Environmental), and other management system certifications, drawing on André's 24 years of best practice management systems consulting.
• Other CE-Marking Consulting (Machinery and Construction Directives) CE-Marking consulting under the Machinery Directive and Construction Directive for non-medical-device products requiring European market access.

Quantifiable outcome

• 90+ medical device manufacturers assisted in obtaining CE-Mark and/or FDA approval
• +1 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record.

• MHRA (Medicines and Healthcare products Regulatory Agency)OthersUK regulatory authority for medical devices. TNMC provides links to MHRA resources for clients requiring UK market access information.
• FDA (Food and Drug Administration)OthersUS regulatory authority for medical devices. TNMC provides links to FDA resources for clients seeking US market approval.
• SAMED (South African Medical Technology Industry Association)OthersSouth African industry association for medical technology. TNMC provides links to SAMED resources.
• RBT247 UKOthers
• RBT247 South AfricaOthers
• African MomentOthers

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• TÜV SÜD: Global testing, certification, and notified body for medical devices with deep EU MDR expertise. Comparable on regulatory affairs, sterilization validation, and CE-Marking, but operates at enterprise scale across multiple verticals.
• Intertek: Global quality assurance and testing company with medical device regulatory and certification services. Comparable on ISO certifications, sterilization, and CE-Marking but competes across many industries.
• SGS SA: World's largest testing, inspection, and certification company with medical device regulatory, ISO, and sterilization services. Comparable across most of TNMC's service portfolio but operates at global scale across many verticals.
• NSF International: Global public health and safety organization offering medical device certification, ISO management systems, and regulatory consulting. Comparable on ISO certifications and medical device regulatory services with broader industry focus.
• BSI Group: Global standards, certification, and regulatory services company operating notified bodies for medical devices under EU MDR. Overlaps with TNMC's CE-Marking consulting, ISO management systems, and sterilization validation services but serves a much broader portfolio across multiple industries.
• DEKRA: International testing, inspection, and certification organization with notified body designations for medical devices under EU MDR. Comparable on CE-Marking, ISO systems, and regulatory services at much greater scale.

Direct peers

• MedPass International: European medical device regulatory consultancy and Authorized Representative service provider. Closely comparable to TNMC's core AR + CE-Marking offering, with similar focus on helping non-EU manufacturers access the European market.
• Emergo by UL: One of the largest dedicated medical device regulatory consulting and EU Authorized Representative services firms globally. Highly comparable to TNMC's AR + CE-Marking + FDA approval offering, but at significantly greater scale and geographic breadth.
• RQM+ (formerly R&Q): Specialized medical device regulatory and quality consulting firm focused on EU MDR transition, clinical evaluation, and quality systems. Closest mid-market peer to TNMC's regulatory and clinical evaluation practice.
• NAMSA: Medical device-focused CRO and regulatory consulting organization offering testing, regulatory, and quality services. Comparable to TNMC's combined regulatory + sterilization + clinical evaluation offering but with substantially larger bench and laboratory infrastructure.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/tnmc-&-tnmc-medical-devices-uk

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries2 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 TNMC & TNMC Medical Devices UK