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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

Brochures, regulations & authorisation documents

Corporate brochures, signed Authorised Representative documents, certificates and the EU regulations we work with daily — everything your procurement team, your notified body or your own regulatory department typically requests, in one place.

Brochures

Company Profile

DE820 KB

EAR Folder

EN744 KB

EAR Folder

JA607 KB

EAR Folder

KO428 KB

EU Regulations

MDR 2017/745 — Medical Devices

EN1.5 MB

IVDR 2017/746 — In Vitro Diagnostics

EN1.4 MB

Certificates

Signed EAR Document

EN444 KB

Signed EAR Document

DE444 KB

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Global network

Local partners in 12 jurisdictions