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:

  • Regulatory Strategy Development
  • Agencies Interaction
  • Product Classification
  • Labelling/Advertising compliance
  • Reviewing and drafting product User Guides
  • Assisting with regulatory submissions in Canada, USA, European countries, Brazil, Mexico, Asia, Russia, China,  India (e.g. 510(k), PMA, Medical Device Licensee, CE Mark, etc.)
  • Assisting with Risk Analysis
  • Assistance with the preparation of Investigational Studies (IDE, ITA)
  • Compliance with the requirements of ISO 14155
  • Post Market Support
  • Recalls Planning and Management
  • Emergency responses to Agencies or Warning Letter