Regulatory Affairs

The medical device industry is one of the most highly regulated in the world. That’s why it’s crucial that medtech companies have a clear picture of their regulatory pathway from the outset of product development to reduce business risk and optimize time-to-market.

It’s exciting and rewarding to be developing new technology that improves our quality of life. However, we recognize that founders don’t start medical device companies because they have a passion for regulatory affairs. That’s where we come in. Let us help you formulate a comprehensive regulatory strategy that aligns with your business strategy and continue to support you as you navigate the regulatory pathway to market authorization and beyond.

Some of the ways we can support you:

• Classify your product under U.S., Canadian, and EU regulations
• Pre-submission liaison with regulators to ensure development activities are aligned with their expectations
• Ensure labelling, packaging and promotional materials meet regulatory requirements
• Prepare regulatory submissions (e.g., FDA 510(k), Health Canada MDL, EU Technical Documentation), and registrations

For lean organizations, we can also act as your outsourced regulatory affairs department as fractional embedded team members.