deenda    (+45) 26 32 44 05      mgj@incor.dk

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.

News

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

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incor

Praestevaenget 4
4450 Jyderup
Denmark
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.

Services
  • Product Development
  • Quality Management
  • Product Registration
  • Innovation