Regulatory Affairs

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Our consultants have regulatory affairs experience in post-approval, submission, and pre-approval activities. In this ever-changing industry, our team can provide regulatory strategies specific to your market goals and product requirements. We specialize in regulatory frameworks in the U.S.A., EU, UK, Canada, and several other international markets. 

Contact us for your next project:

• Regulatory Assessment / Strategy
• Device classification
• Premarket Notification - 510(k)
• Implementation of EU MDR 2017/745 
• Strategy for UK conformity assessment 
• Health Canada submissions
• International regulatory submissions and re-registrations
• Post-market surveillance
• Complaints, medical device reporting, and vigilance reporting