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Logo MDR Competence -  Your Medical Device Consulting  Group

MDR Competence - Your Medical Device Consulting Group

Short description

The aim of the MDR-C is the close and networked cooperation and mutual support for the professional and effective implementation of the MDR by medical device companies as well as by regulatory bodies or other market participants, such as investors or participants in due diligence or M&A activities.

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Description

Our Mission

Our group’s purpose is mutual support and cooperation, so that we can offer our clients a complete service package from one source in complying with and implementing the Regulation (EU) 2017/745 on Medical Devices -EU MDR-.

Our Networks Services

  • Quality and risk-focused consulting and guidance
  • Support in the preparation of MDR-compliant technical
  • Documentation according to Annex II + III
  • Support in due diligence assessments and M&A activities
  • Planning and realization of non-normative V&V test methods
  • Planning and conducting of clinical investigations and clinical evaluations
  • Guidance and testing according to current EMC test requirements
  • Biocompatibility and toxicology testing 
  • Services of the Conformity Assessment Center for Cybersecurity

Location

Düsseldorf, Germany
Heinrich-Heine-Gärten 6
40549 Düsseldorf

Contact

C

Christoph R. Manegold

Founder of the Network