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.

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
  • Labeling

    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
  • ECO / DCO

  • Regulatory impact assessment of design changes
  • Liaison with National Regulatory Authorities
    News and inspiration
    Medical devices: deal reached on new EU rules?

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