Clinical Trials for Medical Devices

Health Canada describes a medical device as “any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state”. From this definition, medical devices can cover a wide range of uses. To further differentiate the types of medical devices out there, Health Canada has divided them into 4 different classes (Class I, II, III, and IV), Class I representing the lowest risk and Class IV representing the highest risk applications.

Manufacturers of medical devices must:

1. Ensure the medical devices meet safety and efficacy requirements as laid out in the Medical Devices Regulations; and,
2. Keep objective evidence to establish that a medical device meets those requirements.

dicentra offers the following services to support medical device clinical trials:

• Feasibility Studies
• Pivotal Studies
• Post-market Studies
• Regulatory Services
• Pre ITA-Application Meeting
• ITA Applications (for class II, III, and IV applications)
• Clinical Trial Applications

Contact us for assistance with clinical trials for medical devices