Regulatory Affairs

ADEQUAT EXPERTISE supports industrials for the development of their new medical devices, with regulatory compliance issues to launch products on the international market. ADEQUAT EXPERTISE assists industrials to understand the different regulatory procedures and can step in the design processus in order to prepare the appropriate documentation to achieve CE Marking for their products.

SPECIFIC COMPETENCES

  • Medical devices CE marking: European directive 93/42/CEE and "Code de la Santé publique"
  • American Regulatory requirements issues
  • Risk management according to the standard ISO14971
  • Materiovigilance (EU - USA)
  • Preparation or review of technical documentation
  • Selection of appropriate procedures for the assessment of conformity
  • Support for medical devices classification
  • Identification of applicable standards
  • Medical devices labeling and packaging : design and validation
  • Preparation of documentation for registration (worldwide)
  • European Mandatory
  • Post market survey

For more information, contact us