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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.

Regulatory Consulting for Medical Devices – Your Medtech Consultant for CE Marking and FDA Approval

Navigating the regulatory landscape of medical devices can be challenging—especially as requirements for CE marking, FDA registration, and other standards continue to evolve. At Medos, we offer expert consulting services in regulatory affairs for medtech companies aiming to bring their products to market quickly, safely, and in full compliance with current legislation.

CE Marking for Medical Devices – End-to-End Support

CE marking is a fundamental requirement for selling medical devices within the EU. Our regulatory consulting helps you understand and meet MDR requirements, whether you're developing a class I product or a high-risk medtech innovation. We act as your dedicated partner and consultant throughout the process—from technical documentation and risk management to clinical evaluation and communication with notified bodies.

FDA and Global Market Access

For companies looking to expand into the US market, we also provide full support with FDA requirements and 510(k) submissions. Our regulatory consulting covers the entire process—from classification to final submission—ensuring the best possible chance of FDA approval. We also act as your strategic consultant for other global markets, where both CE marking and FDA approval are key to success.

Medtech Expertise That Makes a Difference

As a specialized medtech consultant, we work closely with both startups and established companies in the medical device industry. Our strength lies in combining technical insight with deep regulatory knowledge—we know what it takes to move an idea from prototype to CE-marked and commercially viable product.

Our Regulatory Consulting Services Include:

  • CE marking according to MDR and IVDR

  • FDA submissions and 510(k)

  • Regulatory gap analyses and compliance strategies

  • Review and preparation of technical documentation

  • Consultant support in communications with authorities and notified bodies

Contact Your CE Marking and Medical Device Consultant

Looking for an experienced partner for CE marking, FDA approval, or other regulatory consulting in the medical device sector? Medos is your trusted medtech consultant, helping you get your product to market in the most efficient and compliant way. Contact us today for an initial consultation.