Finding your way around Regulatory requirements

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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Being your global partner within RA/QA we would like to share our new RA blog with everybody who has an interest in what is going on in the complex world within regulatory affairs and medical devices.

Keeping you up-to-date with RA/QA
During the last 10 years, the evolvement of legislative requirements within the RA/QA and medical devices area has expanded massively. Working within the RA/QA area being on forefront with new and constantly changing legislation can be a daunting challenge – we would therefore like to help you gain an overview.

On we will post news and articles describing different issues within RA/QA enabling you to be on the forefront with legislative issues worldwide.

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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