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Regulatory Services

Our consultants have many years of experience with regulatory affairs for medical devices, working with products across various technology domains and all risk classes. We can support you with advisory services for CE marking, FDA applications, handling registration matters, and preparing for launches in other markets.

We assist with areas including MDR and IVDR, FDA, ISO 13485, EN 62304, ISO 14971, ISO 27001, and more.

Our consultants have many years of experience with regulatory affairs for medical devices.

Regulatory Expertise

Medos consultants are experts in regulatory affairs. We have supported hundreds of startups and scale-ups in developing and implementing smart regulatory strategies.

We can also provide additional resources by taking on roles such as Quality Manager, Regulatory Manager, or PRRC (Person Responsible for Regulatory Compliance). However, our ultimate goal is for you, as our client, to grow and become self-sufficient.

  • Regulatory Strategy
  • CE Marking
  • FDA Applications (510(k), De Novo, PMA, etc.)
  • PRRC (Person Responsible for Regulatory Compliance)
  • Qualification and Classification according to MDR, MDSAP, FDA 21 CFR, or other regulations
  • Gap Analysis of management systems and technical documentation
  • Authoring and Structuring of technical documentation
  • Expert Support for Design Controls according to EN 62304
  • Support with Risk Analysis according to ISO 14971
  • Information Security and Cybersecurity
  • Clinical Evaluation

We can also assist you in modernizing your QMS, conducting internal audits, managing supplier control, performing management reviews, PMS/PMCF, and handling all other QA-related matters.

Read more about our offering in Quality Management.

Project Mangement

We can take on a role as a dedicated advisor in QA/RA, but more often, our clients want us to take a more active role with operational responsibility for preparing technical documentation and managing application processes for CE marking or FDA submissions. Regardless of how you want us to support you, we guarantee that the consultant assisting you will have specialist expertise and provide genuine personal commitment.

Read more about our offering in Product Development.

Pre-study

Our medical device pre-studies are renowned for their level of detail. A comprehensive pre-study often includes not only a classic regulatory strategy (intended use, qualification, classification, applicable standards, etc.) but also a documentation review and a technical and business analysis, which can be highly valuable in the early stages.

The focus is often on CE marking under MDR or IVDR, as well as market authorization in the U.S. through FDA submissions.

CONTACT US FOR A QUOTE!

We give you the courage to go for it!

On your terms

We have worked with startups and small innovation companies in the medical device industry for many years. We understand the challenges our industry presents. You can count on us to be by your side with expertise and resources, even as your ideas and needs evolve. With us, you’ll benefit from personal relationships and genuine commitment. We aim to work with you long-term — on your terms.

We have worked with startups and small innovation companies in the medical device industry for many years.