Validate your medical device and be first to market
The realm of medical devices is vast, with new opportunities emerging every day as technology and healthcare advance. In the competitive market, there’s no substitute for a launch that is quick and backed by clinical evidence.
Our clinical trials team brings expertise across multiple areas of health and wellness, along with hands-on experience designing and managing clinical trials for a range of medical devices.
We can assist you with medical device claims validation, clinical trial design, virtual clinical trials, regulatory support through both Health Canada and the FDA, and more.
We can help you:
- Develop a clinical trial plan
- Engage with regulators (Health Canada, FDA) on your behalf
- Design clinical trial and prepare a study protocol that meets regulatory standards
- Identify risks early enough to mitigate them
- Assess study feasibility
- Determine the appropriate target population
- Select the right endpoints
- Manage your data and ensure regulatory compliance.