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

 

Medical Device Services for Canada