Regulatory Compliance

Your path to compliance!

With the growth of the medical device industry, introduction of new measures and rapid advancement of technology, medical device manufacturers aim to take full advantage of globalization by accessing worldwide markets.

Based on our expertise of product development, clinical validation, and international regulatory submission processes as well as all imposed requirements thereto, we can customize a regulatory solution based on our customers’ particular needs and targeted global marketing strategies. We help our customers to structure and formalize all necessary steps in organizing their affairs so they may meet their goals. Over the years, LOK has supported hundreds of customers across the development spectrum and notably with respect to the following:

  • Regulatory Strategy Development
  • Agencies Interaction
  • Product Classification/Predicate Device Searches
  • Labelling/Advertising compliance
  • Reviewing and drafting product User Guides
  • Assisting with regulatory applications
  • Post Market Support
  • Recall Planning and Management
  • Emergency responses to agencies concerns, warning and decisions.