In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

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The Voluntary Improvement Program (VIP) helps device makers design, build and deliver safer products to patients, faster. Developed in collaboration with ISACA, MDIC, FDA and the medical device industry as part of FDA’s case for quality initiative, this program identifies process inefficiencies and helps device makers implement best practices that accelerate medical device improvements. Participant outcomes include increased speed to market, improved production capacity, reduced regulatory burden & more.

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Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

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