Medical Device Development
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
Medical device diagnostic experience
Across the diagnostic device spectrum, PPD’s medical device team provides strategic and clinical trial support for new diagnostic devices and indications. Our experience includes simple normal and healthy sample collection and rigorous investigational device exemption (IDE) trials required by the FDA.
PPD offers substantial experience in device and diagnostic study execution, strong leadership and significant regulatory experience with the Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety and the Center for Devices and Radiological Health (CDRH).
We understand the unique challenges of medical device development across the life cycle: intense competition, precise regulatory requirements, and shortened product exclusivity and life cycle. Our highly experienced medical device specialists provide innovative, results-focused support for our customers’ post-marketing needs.