Regulatory Compliance

Understanding Health Canada and the FDA’s needs and requirements is only the first step

LOK North America supports hundreds of clients across the development spectrum and notably with respect to the following:

  • Development / elaboration of regulatory strategies
  • Determination of the risk class of products
  • Support for the development of marketing applications (i.e. Canadian licenses, 510(k), De Novo, PMA (USA), CE Marketing (Europe), etc.)
  • Interaction with regulatory agencies (i.e. FDA and Health Canada)
  • Interaction with testing laboratories and other contributors (i.e. biocompatibility and electric certifications)
  • Labelling and advertising compliance
  • Revision and writing of user guides or user manuals
  • Post-market support (i.e. materiovigilance, recalls, mandatory disclosures)
  • Regulatory watch
  • Training in several areas (i.e. quality systems, regulatory, software verification and validation)