Technical documentation

We create or review your technical documentation and make is ready for MDR/ FDA

Technische Dokumentation - Medtech360

Our offer

  • Project-accompanying creation of technical documentation (MDR-compliant)
  • GAP analysis of your technical documentation with regard to MDR requirements

Do you need support with your technical documentation?

Contact us at any time for a free initial consultation.

To the inquiry

Technical documentation in medical technology

The technical documentation (product file) verifies the conformity of your products with European and international regulations and directives.

It does not matter which risk class the medical device is subject to.

Complete and comprehensive technical documentation in accordance with MDR Annex II is of great importance for the successful approval of your products and accelerates the examination by the notified body.

MEDTECH360 will be happy to support you in setting up, analyzing or revising the technical documentation for your products. Get in touch with us!