MT Promedt Consulting

What MT Promedt Consulting does

MT Promedt Consulting GmbH is an EN ISO 13485:2016 certified regulatory consultancy headquartered in Sankt Ingbert, Germany, providing analytical and strategic services to international manufacturers of medical devices, in vitro diagnostics (IVDs), pharmaceuticals, and biotechnology products. Founded in 1995, the firm specialises in European and UK regulatory pathways and serves non-EU manufacturers requiring an in-region legal representative for market access under MDR (EU) 2017/745 and IVDR (EU) 2017/746. Its core offerings span European Authorised Representative (EAR) services, UK Responsible Person (UKRP) services, strategic regulatory consulting for CE marking, ISO 13485/9001 quality management system implementation, international product registration across twelve-plus jurisdictions, and customised training on European regulatory requirements.

The company's core technology is deep human regulatory expertise rather than a software platform. MT Promedt holds EUDAMED economic-operator status under SRN DE-AR-000000085 and operates a multi-jurisdiction legal representation model (EAR / UKRP / CH-REP) through owned offices in St. Ingbert (DE), Salt Lake City (US), and Oxford (UK), complemented by a partner network covering Australia, Brazil, Israel, Japan, Korea, Saudi Arabia, Singapore, and the USA. Service delivery is consultant-led via B2B engagements with medical device and IVD manufacturers; the firm monetises through project-based consultancy fees for CE marking, technical documentation review, clinical evaluation, post-market surveillance, QMS implementation, and annual retained representation mandates. Marketing is concentrated on industry tradeshows (Medica, Kimes, World Health Expo) and direct B2B inquiry.

Ownership is private and held by management — Managing Director Christoph Leder leads the firm — with no disclosed venture capital or private equity backing, no public listing, and no disclosed M&A activity. The company has shown incremental geographic expansion (UK in 2021) and product-line extension (training, multi-jurisdiction representation) but operates as a focused specialist consultancy rather than a venture-stage or hyper-growth business.

Name

MT Promedt Consulting

Legal name

MT Promedt Consulting GmbH

Website

https://mt-procons.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

1–10 employees

Short description

MT Promedt Consulting GmbH, a German regulatory consultancy founded in 1995, provides EAR services, strategic regulatory consulting, quality management, and international product registration to medical device and IVD manufacturers worldwide through offices in Germany, the USA, and the UK.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE)

Keywords

• Regulatory affairs consulting
• Medical device compliance
• Authorized representative services
• Quality management systems
• IVD regulatory services

Headquarters

HQ city

Sankt Ingbert

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Infrastructure, Others

Revenue model

1. Regulatory Consultancy Services: Professional consulting services for medical device regulatory compliance including strategic regulatory consulting, quality management systems, and international product registration. Revenue generated through consultancy fees for B2B clients seeking regulatory approval and market access.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

MT Promedt Consulting is an EN ISO 13485:2016 certified regulatory consultancy providing analytical and strategic services for medical device, in vitro diagnostic (IVD), pharmaceutical, and biotechnology manufacturers. The firm acts as European Authorised Representative (EAR) and UK Responsible Person (UKRP) for non-EU manufacturers, and delivers strategic regulatory consulting, quality management system implementation, international product registration, and customised training programs covering CE marking, technical documentation, and post-market surveillance.

Product overview

MT Promedt Consulting is an EN ISO 13485:2016 certified regulatory consultancy providing analytical and strategic services to the international healthcare market. The company operates as a services-based consultancy rather than a software product company, offering a portfolio of interconnected regulatory services: European Authorised Representative (EAR) services for EU market access under MDR/IVDR, UK Representative services for UK market access, Strategic Regulatory Consulting for CE marking and compliance, Quality Management Systems implementation, International Product Registration across multiple global markets, and custom Training programs. These services are designed to support medical device and IVD manufacturers throughout the product lifecycle from development to post-market surveillance.

Differentiator

Problem solved

Functional benefit

Products and services

• European Authorised Representative (EAR) Services Acts as the legally required Authorised Representative for non-EU medical device and IVD manufacturers under MDR (EU) 2017/745 and IVDR (EU) 2017/746. Services include EU address provision, verification of technical documentation, interaction with competent authorities, and vigilance support.
• Strategic Regulatory Consulting Comprehensive support for European pre- and post-market compliance, including CE conformity assessment procedures, risk management file preparation per ISO 14971, clinical evaluation, post-market surveillance, and technical documentation review for medical device and IVD manufacturers.
• Quality Management Systems (QMS) Consultancy services for QMS implementation according to EN ISO 13485 and EN ISO 9001, including CAPA process implementation and compliance audits for medical device, IVD, pharmaceutical, and biotechnology manufacturers.
• International Product Registration Regulatory support for market entry strategies across international markets including Europe, Australia, Brazil, Canada, China, Israel, Japan, Korea, Saudi Arabia, Singapore, UAE, and the USA. Includes acting as in-country representatives and local license holders.
• Regulatory Trainings Customised international training programs on European regulatory aspects for medical device and IVD manufacturers, covering CE marking, technical documentation preparation, risk management per ISO 14971, clinical evaluation, post-market surveillance, vigilance requirements, and quality management systems.
• UK Representative Services (UKRP) Provides UK Responsible Person (UKRP) services via the UK office in Oxford (subsidiary MT Promedt Consulting Ltd) to support medical device and IVD manufacturers with registration of their devices with the MHRA for the UK market.

Segments4 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

One partnership is on record.

• Global Network Partners (Australia, Brazil, Israel, Japan, Korea, Saudi Arabia, Singapore, USA)coreStrategic or Co-development PartnerMT Promedt Consulting maintains a global network of subsidiaries and partners in Australia, Brazil, Israel, Japan, Korea, Saudi Arabia, Singapore and the USA. Through this network, the company provides in-depth knowledge across the lifecycle in medical technology from product development to the post-market period. These partners facilitate international product registration and market access support for medical device manufacturers.

Scale indicators2 records

Recent moves7 records

Expansion highlights5 records

Market position

Competitive moat5 records

Key risks4 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

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 MT Promedt Consulting