Medical Devices
Worldwide strategic planning and regulatory consulting services for medical devices
The regulatory environment for medical devices and device, drug and biologic combination products changes rapidly and impacts the entire product life cycle. The Regulatory & Quality Practice within Consulting at Quintiles provides strategic planning and other regulatory consulting services that medical devices companies need to maintain their competitive advantage. We help companies optimize the development process and the regulatory pathways for quickly bringing new devices to market and keeping them there for commercial success.
Our global team works in an integrated manner to fulfill regulatory and quality needs for medical devices clients to develop and implement R&Q strategies and programs in all major markets of the world.
The U.S. based group combines more than 50 years of experience as former U.S. Food and Drug Administration (FDA) reviewers, supervisors and managers at the FDA's Center for Devices and Radiological Health (CDRH); and almost 100 years of experience in the device industry. That experience extends across virtually all device types, including in vitro diagnostics and device/drug/biologic combination products. It also extends across all types of companies from start-ups to long-established organizations. Over our more than 15 year history with diverse device types, we've worked with virtually every device review organization within the FDA.
The European team brings experience from private companies, standards organizations, notified bodies and competent authorities. We provide the strategic planning and regulatory support for breakthrough products as well as for advanced innovations within existing product lines for virtually all therapeutic and diagnostic devices or combination and borderline products.
With our extensive experience and global perspective we provide comprehensive support and medical device expertise:
- Strategic planning and regulatory consulting
- Designing and establishing quality systems and support for start-up and established companies
- Optimizing the Design Control and Risk Management processes
- Supporting and/or managing regulatory processes and preparing submissions
- Providing R&Q support for mergers and acquisitions
