510K & CANADIAN MEDICAL DEVICE REGULATIONS

Medical devices include a wide range of products including pacemakers, artificial heart valves, hip implants, syringes, medical laboratory diagnostic instruments,  and contraceptive devices. From medical device classification to establishment registration, we provide all of the services necessary to enter the United States and Canadian marketplaces with your medical device.

Medical Device Services for the Unites States

  • Regulatory strategic planning and product classification
  • Facilitate interaction with regulatory agencies during development stages, submissions and submission approval process
  • Liaison with regulatory agencies on regulatory, CMC, clinical and toxicology matters
  • Respond to regulatory agency questions
  • Provide expert regulatory CMC compliance advice throughout development
  • Determine which similar (predicate) devices already have FDA 510(k) clearance and whether they are suitable for use in your 510(k) submission.
  • Review testing requirements, applicable FDA guidance documents and required standards
  • Provide a detailed product-specific list of documents needed for review by our 510(k) consulting team
  • Provide a detailed list of documents, reports, diagrams or clinical data needed before 510(k) preparation can begin
  • Prepare a technical comparison of your medical device to other predicate devices with FDA 510(k) clearance
  • Medical Device Reporting
  • Label review for compliance with 21 CFR part 801

Medical Device Services for Canada

  • Regulatory strategic planning and product classification
  • Organize and manage meeting with the Therapeutic Products Directorate (TPD)
  • Prepare and file CTA’s (Clinical Trial Applications)
  • Prepare and file Class II, III and IV applications
  • Provide application support during TPD review
  • Perform Quality System audits
  • Provide label and advertising review
  • Resolve regulatory compliance issues