Regulatory Affairs

Ensuring that your company complies with all of the regulations and laws pertaining to your business can be challenging.

Still, working with global or local authorities and regulatory agencies on specific issues affecting your business is an important part of bringing new products to market and continuously apply to revised laws and regulations.

Based on insight and deep understanding of the medical device business our consultants can ensure a well-structured and time reducing regulatory process from first idea to post market surveillance.

We can help you with
Go to market strategy
  • Financial validation
  • Business case
  • Market and competitor analysis
Regulatory Pathway
  • Definition of Medical Device/IVD
  • Classification of Medical Device / IVDs / Combination Products
  • Regulatory Pathway
CE mark / FDA / International Registration

  • Preparation and submission of international reg. applications
  • Preparation and submission of US FDA regulatory documentation
  • CE labeling according to MDD/IVD – MDR/IVDR
  • Re-registration (Int.) / re-certification
PMS – Post Market Surveillance

  • PMS – Post Market Surveillance
  • Vigilance

Clinical Evaluations

Biocompatibility Studies

Re-registration and Re-certification

  • Re-registration (Int.) / re-certification (CE)
  • Regulatory impact assessment of design changes
Qualified Person

EU Representation

  • EU authorized representative
  • Qualified Person

  • Regulatory impact assessment of design changes
Liaison with National Regulatory Authorities

Ask Me

Michael Funder Managing Director B.Sc Engineering Direct (+45) 22 47 01 55

Book a visit

Ask Me

Vibeke Harbud Business Development Consultant eMBA, HD(A) Direct (+45) 26 11 70 33

Book a visit