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ISO 13485 implementation

Medical Device RA & QA Team

The Medical Device RA & QA team consists of specialists with a high level of expertise within Regulatory Science and Quality Assurance of Medical Devices. The team of consultants can assist your company with defining and implementing the regulatory strategy on how to market new or innovative medical devices – from idea to marketing. We have in-depth experience with:

  • Successful development of Medical Devices.
  • Timely product registration in EU (CE marking), US (IDE, PMA, 510(k)), Asia, etc.
  • Writing clinical evaluations / medical writing.
  • Writing technical files, design history files, and product submissions incl design dossiers.
  • Vigilance processes for Medical Devices including reporting of adverse events to relevant authorities and Market Corrective Actions (Recalls).
  • Defining and implementing Quality Management System procedures required to market Your Medical Device.

For more information about our Medical Device services, please contact Henrik Dörge, VP of Innovation, Nordics.

Downloads: General Safety and Performance Requirements (MD and IVD) – click here