Services

Services

Benefit from our RA QA expertise

Our Services

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Regulatory

Our regulatory affairs services offer consultancy on:

  • CE Marking.
  • Directives MDD/MDR
  • IVD/IVDR, AIMD, MD, LVD
  • EMC, ROHS, REACH, red ETC.
  • Applications/registrations: FDA
  • Gap analysis (Product standard)
  • Due diligence
  • Build technincal file
  • Project Manager
  • Moderator in workshops for e.g. Risk/Usability standard
  • Set up Regulatory strategy
  • Regulatory Affairs Manager
  • Various support for test house issues
  • Participate as RA/QA during development
  • Investigations


Quality

Our quality expertise is extensive and covers:

  • Participation in development projects
  • Gap analysis (process)
  • Quality System build
  • Quality Assurance Manager
  • Issue SOP/process documents
  • Investigations
  • Participate in audits
  • Lead Auditor
  • FDA mock-up audit
  • Various support for test house issues




Due Diligence

We can participate in due diligience activites prior to a potential acquisition when evaluating a target company or its assets for an acquisition.


We can evaluate the companys' regulatory and/or quality status and provide valuable feedback.

Education

We offer company specific courses which we instruct.


  • CE-marking incl. MDR
  • IVDR, MDR
  • Usability 
  • Product development
  • Risk management
  • Software and apps 
  • 60601- standard series 
  • 61010-standard series 

Standards

Standards and standardization:

  • IEC/EN 60601-1
  • IEC/EN 60601-1-X
  • IEC/EN 60601- 2-X
  • UL/CAN/CSA/AAMI for 60601-series etc.
  • IEC/EN 61010-1
  • IEC/EN 61010-2-101
  • IEC/EN 61010-2-081,
  • IEC/EN 61010-2-XX


Process standards as:

  • IEC/EN 62366-1 (Usability)
  • ISO/EN 13485 (Quality system)
  • ISO/EN 14971 (Risk management)
  • IEC/EN 62304/82304 (Software)