Regulatory Affairs Management

MEDTECH360 helps you with the approval of your products for the European (CE) and American markets (FDA)

regulatory affairs - medtech360

Our Offer

  • Classification of medical devices (MDR: I, Is, Ir, Im, IIa, IIb, III; FDA: Product Code)
  • Implementation of legal requirements according to MDR (EU 2017/745)
  • Processing of the approval of your medical device according to the defined conformity assessment procedure
  • external PRRC (up to a number of employees of 50 you do not need an internal PRRC (Article 15 person) but may outsource these activities to us
To the inquiry

Do you need support with your regulatory affairs management?

Contact us at any time for a free initial consulting.

To the inquiry

Regulatory affairs management in medical technology

Regulatory affairs is becoming increasingly important in medical technology. Every economic area wants to protect its citizens in the best possible way and only provide safe medical devices – but the requirements for this are sometimes very different.

This requires precise planning of the target markets and timely communication with authorities, as well as extensive knowledge of the respective national requirements for medical devices.

We have the experience and are happy to support you! We always ensure that your product complies with the applicable regulations and is successfully approved in the desired markets.