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Independent regulatory consultancy and EU Authorised Representative for medical device and IVD manufacturers since 1995.

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Contact Info
Location Ernst-Heckel-Straße 7, 66386 St. Ingbert, Germany
Contact Info
Location Ernst-Heckel-Straße 7, 66386 St. Ingbert, Germany

Our locations

Three offices, one regulatory partner — serving medical device and IVD manufacturers across the EU, UK, and the United States.

1995
Founded
30+
Years of expertise
3
Offices worldwide
12
Jurisdictions covered
Where we operate

Local presence where regulators sit. Global coverage where you sell

Each of our offices was opened to be on the ground next to a key regulator — the EU institutions in Germany, the FDA in the United States, and the MHRA in the United Kingdom. Together they let us cover every major Western market under one contract.

Germany · Headquarters

St. Ingbert

EU Authorised Representative since 1995

Ernst-Heckel-Straße 7
66386 St. Ingbert, Germany

USA · Liaison office

Salt Lake City

FDA-related projects & US agent services

41 North Rio Grande Street, #100
Salt Lake City, Utah 84101, USA

UK · UK Responsible Person

Oxford

UK RP services since January 2021

First Floor, Park Central
40-41 Park End Street
Oxford, OX1 1JD, United Kingdom

Partner network

Twelve regulatory partners. One global reach

Beyond our three own offices in Germany, the United States and the United Kingdom, we work with twelve vetted regulatory consultancies across the Americas, the Middle East, Asia and Australia — all under one contract. Hover the pins to see who covers what.

World map showing MT Promedt Consulting jurisdictions MT Promedt Consulting St. Ingbert, Germany HQ · EU Authorised Representative MT Promedt Consulting Salt Lake City, USA FDA projects · US agent MT Promedt Consulting Oxford, United Kingdom UK Responsible Person M Squared Associates United States M Squared Associates Regional partner Canada North America regional partner MANDALA International Brazil & LATAM MANDALA International L.S Marketing & Registration Israel L.S Marketing & Registration Medical Regulations Gate Saudi Arabia & UAE Medical Regulations Gate CODEX Professional Translations China CODEX Professional Translations CRCS China CRCS · NMPA Qualtech Taiwan · Asia-Pacific Qualtech Stendard Korea Stendard Kawasaki Legal Services Japan Kawasaki Legal Services CubicPharma Singapore & Malaysia CubicPharma Brandwood Biomedical Australia Brandwood Biomedical
Own office Regulatory partner