510K & CANADIAN MEDICAL DEVICE CONSULTING

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.

COVID-19 Update: New Product Pathways for Canada & United States

If you are looking for more information on new product pathways available to manufacturers in response to shortages, please read the following articles:
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Health Canada Regulatory Exemptions

Health Canada has recently announced a number of actions they’re taking in the fight against the COVID-19 Pandemic.

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FDA & EPA - Pathways for Products

FDA & EPA have made changes and exemptions to existing regulations in order to assist companies in getting these vital products to market.

Medical Device Services for the United 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(s) 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