Regulatory Services

We are offering a full set of regulatory services



Our Regulatory Services will guide you through the various (inter)national and local regulations to assure compliance and access for the market of interest.

With the expansion of the markets on a global scale, regulatory compliance strategies require a broader approach and view point in order to scale your strategy to include the various country specific demands.

Regulatory Strategy

Regulatory strategy is depending on the market you would like to enter. Continuous development of medical device laws has increased the detail of regulatory compliance and practical implementation of the requirements.

Technical documentation has become more detailed and standardized with required information.

MedQ Consultants B.V. can support you in:

  • Regulatory strategy for the European and other global markets
  • Provide support for compliance against the regulatory market(s)
  • Technical documentation
  • Market approval/release and access for the European market as well as globally
  • Being your Authorized Representative

    • Authorized contact for non-EU companies.
    • Vigilance and Safety reporting.
    • Medical Device Market registration and Approval support

Regulatory consulting services

The most important element of getting your medical device approved is the implementation of a fundamental regulatory strategy and sound technical documentation. Our regulatory service provides you guidance and support to comply with the current medical device regulation(s) and market access requirements. With a tailor-made service package we can provide excellent and efficient support in preparing access to the European/global market

MedQ Consultants B.V. can support your regulatory requirements with:

  • Regulatory strategy
  • Liaison for Notified Body, Competent Authority, European Commission
  • CE marking guidance
  • Prepare / review risk analysis
  • Prepare / review Essential Requirements
  • Declaration of Conformity
  • Instruction for Use / Labeling
  • Clinical evaluation report
  • Regulatory training
  • Being your internal regulatory employee / support

More Information

You require additional information about our Regulatory services? Do not hesitate to contact us!