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.

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We can help you with

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Go to market strategy
  • Financial validation
  • Business case
  • Market and competitor analysis

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Regulatory Pathway
  • Definition of Medical Device/IVD
  • Classification of Medical Device / IVDs / Combination Products
  • Regulatory Pathway

[divider type=”line” margintop=”10″ marginbottom=”10″]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

[divider type=”line” margintop=”10″ marginbottom=”10″]PMS – Post Market Surveillance

  • PMS – Post Market Surveillance
  • Vigilance

[divider type=”line” margintop=”10″ marginbottom=”10″] Labeling

[divider type=”line” margintop=”10″ marginbottom=”10″] Clinical Evaluations

[divider type=”line” margintop=”10″ marginbottom=”10″] Biocompatibility Studies

[divider type=”line” margintop=”10″ marginbottom=”10″]Re-registration and Re-certification

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

[divider type=”line” margintop=”10″ marginbottom=”10″] Qualified Person

[divider type=”line” margintop=”10″ marginbottom=”10″]EU Representation

  • EU authorized representative
  • Qualified Person

[divider type=”line” margintop=”10″ marginbottom=”10″]ECO / DCO

  • Regulatory impact assessment of design changes

[divider type=”line” margintop=”10″ marginbottom=”10″] 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