Medical Device Development - Design and Prototype Stage
You have a great idea for a new medical device. Perhaps you completed an initial business plan, defined the market for your device, identified performance specifications, and are refining clinical uses based on your core technology and the results of bench and animal testing.
Many of the decisions you make now can have tremendous impact on the success of your project. By anticipating the regulatory and clinical trial requirements associated with your new product now, you can address questions that will improve its chances of successfully being approved or cleared.
MDCI can help you with your medical device development strategy by identifying a product-specific regulatory strategy for both U.S. and OUS product introductions.
Specifically, we can help you to:
- Assess the impact of regulatory environment and FDA policies
- Assess applicable Medical Device Directives and individual country requirements
- Determine product classification and essential requirements
- Identify which FDA Center will have jurisdiction for drug-device and biologic-device combination products
- Design and review your pre-clinical test plans and clinical studies
- Review and evaluate your technical and clinical data, including labeling reviews and risk management determinations
- Help you to begin a collaborative dialog with the FDA through formal pre-IDE meetings or informal communications
- Serve as your liaison with Notified Bodies and Competent Authorities
- Define and assess your product labeling claims and associated clinical data requirements
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Client Testimonial
I look forward to working with you to complete the entire process and to celebrate the ultimate success of achieving FDA 510(k) clearance. I cannot think of better partners or a better team to achieve this final result!
- U.S. manufacturer and developer of a dental device