Medical Devices and Diagnostics

Almost no other regulated industry sector has experienced the regulatory innovation and change found in today’s medical device and diagnostic sectors. From EU MDREuropean Medical Device Regulation and FDA’s stated ISO 13485 alignment, to MDSAPMedical Device Single Audit Program, GUDIDGlobal Unique Device Identification Database, cybersecurity and VSMRVoluntary Malfunction Summary Reporting, the medical device and diagnostic sector is dealing with accelerating product innovation, digital convergence and a rapidly evolving, globally aligned regulatory landscape.  For companies play a crucial part in addressing patient disorders, providing quality treatment options, and improving patient outcomes, this confluence of challenges often necessitates expert help and assistance from innovators and problem solvers.

Our expert consulting leadership team has experience from the plant-floor to the C-Suite and have navigated some of the most complex issues for leading medical device and diagnostic companies. Risk Management for MD&D Manufacturers from the 2021 American Medical Device Summit