Medical Device Development
Medical device trials are unique — we have the experience and expertise to support them
Medical device trials tend to be smaller than drug trials, but they are no less complex. Difficult to blind, randomize and control, they demand specialized experience and the flexibility and expertise to understand how to leverage user feedback to optimize your product.
Our clinical, regulatory and marketing services focus on bringing medical devices to market and then supporting them throughout the life cycle. We dedicate resources to every project, working as an extension of your staff. Our full-service support coupled with our vast expertise across therapeutic areas maximize results.
Specific regulatory experience
Our extensive experience in all classes of medical devices and diagnostics and exacting regulation requirements can help you save time and money. Whether your medical device is targeted to domestic or global markets, we can help you overcome the challenges of an ever-evolving global regulatory environment. With offices in 46 countries, we have the global resources and local regulatory knowledge to facilitate effective strategies for approval.
Working in partnership with a pre-eminent physician network and experienced consultants, we provide FDA regulatory compliance strategy for medical device development, including:
- FDA submissions
- FDA meeting preparation, attendance and follow-up
- Quality assurance auditing and compliance
- Quality system design and assessment
- Employee training and document control
