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.

EUMEDIQ Regulatory World Map

The EUMEDIQ Regulatory World Map is a concise guide for medical device manufacturers who want to conquer new markets with their products, a tool for access and regulatory strategy for the export of MedTech devices. We specifically help players in the field to gain an overview of the most important country-specific requirements for their products. 

Discover new potential expansion markets, immerse yourself in the specific requirements for each product class and contact us for input and questions.

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That's why EUMEDIQ

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

EUMEDIQ in numbers

Experience

Ø Years of employee experience in MedTech
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Employee Training

Ø Training days per employee per year
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Sites

Frankfurt, Zug and London
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Audit Business

Audit customers
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Representative Business

Technical files under contract
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Representative Business

Devices under contract
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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

Import (Regulatory)

Regulatory import and Authorised Representative services from one single services provider.

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