deenda    (+45) 26 32 44 05

The development of medical devices has become subject to a more stringent regulation with the new Medical Device Regulation 2017/745. Among other, greater emphasis is placed on.

  • Risk management during the entire product life-cycle
  • Clinical evaluation
  • The table of contents for the technical file is prescribed.
  • UDI-DI og UDI-PI codes on labelling.

It is recommendable to register new products according to the new regulation. We can coach you in that process.


The new MDR, Medical Device Regulation (EU) 2017/745 is now statutory from the 5th of April 2017

In year 2020, after a transitional period of three years, all development of medical devices and its documentation has to comply to the new regulation



About us


Contact us


Praestevaenget 4
4450 Jyderup
Phone:  +45 26 32 44 05
Fax: +45 69 80 44 05

WEEE-Reg.-No: 38 48 13 20
VAT No: 38 48 13 20

About us

incor is based upon more that 30 years of experience in developing medical devices within several clinical disciplines; among others intensive care, cardiology, and functional diagnostics. Moreover, we have experiences in developing and maintaining of quality systems according to ISO 9001 and ISO 13485.

  • Product Development
  • Quality Management
  • Product Registration
  • Innovation