Unmatched expertise in international MedTech

Our integrated services Authorised Representation, Medical Device Consulting, Import, and Auditing, comprehensively support Medical Device manufacturers bringing their products to the MedTech market – ensuring their safety and compliance.

Switzerland, United Kingdom and European Union

Expertise & Experience

We are an internationally operating service provider – headquartered in Switzerland – comprising experts in tailored solutions within Regulatory Affairs and Medical Devices. We serve as an Authorised Representative and importer in Switzerland, the United Kingdom, and the European Union. Furthermore, we provide audit services according to information security management systems (ISMS) ISO 27001 and medical device quality management systems ISO 13485. Our consulting services encompass medical device compliance within the comprehensive product life cycle.

Our goal: Accompanying medical device manufacturers – from idea to successful market launch.

Our vision: Safety through digitalisation.

Today, we help companies to further expand their innovative edge and staying up to date.

That's why EUMEDIQ

Passionate, experienced team with the goal of making medical products available on the market as simply as possible
Accumulated expertise from the life science industry, in regulatory, data security and IT
Flexibility and transparency with a non-hierarchical team organisation
Simple order processing thanks to fully digitalised and automated processes
Digitalisation focus as a core competence
Our knowledge is continuously implemented in our processes

EUMEDIQ in numbers

Experience

Ø Years of employee experience in MedTech

Employee Training

Ø Training days per employee per year

Sites

Frankfurt, Zug and London

Audit Business

Audit customers

Representative Business

Technical files under contract

Representative Business

Devices under contract

Authorised Representative Services

Easy access to market: 1x effort for you – 3x market approval in Switzerland, the United Kingdom and the European Union.

Medical Device Consulting

Focus on data protection and security, product development and verification and validation, computer systems validation and regulatory strategy consulting.

Auditing Services

Certified Lead Auditors auditing…

Management systems (ISO 13485 and MDSAP, ISO 27001) according to ISO 19011
Conformity assessments for MDR EU 2017/745 and IVDR EU 2017/746 Annex IX, X and XI
Gap assessments medical device software IEC 62304, IEC 82304 and usability engineering IEC 62366
Gap assessments US HIPAA, US 21 CFR Part 11, GMP Part 11