Regulatory Sciences
FAQ: In Vitro Diagnostics (IVDs)
Question & Answer with IVD Expert, Cortez McBerry, PhD The Future of IVDs: How Point-of-Care Testing and Diagnostic Miniaturization Are Transforming Healthcare In vitro diagnostics (IVDs) are rapidly...
Quality & Compliance
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths
The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...
Regulatory Sciences
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Quality & Compliance
Roadmap for Successful IVDR Transition
Roadmap for Successful IVDR Transition: The compliance dates for the In Vitro Diagnostics Regulation (IVDR) will become effective on May 26, 2022. To help you with the IVDD to IVDR transition, we've...