Compliance Corner: 4 Things You Should Do Now To Prep For FDA’s New QMSR Reg
Executive Summary
Morgan Lewis partner Dennis Gucciardo says there are steps device makers can take to make sure they’re not caught behind the 8 ball once the US FDA’s proposed Quality Management System Regulation is finalized.
You may also be interested in...
Industry To FDA: 1 Year Isn’t Enough Time To Transition To New QMSR Rule
Stakeholders and industry groups at a 2 March US FDA panel meeting said two years, not one, will be needed for device makers to comply with the agency’s proposed Quality Management System Regulation, which when finalized will replace the current Quality System Regulation.
QMSR Quick Take: Medtech Consultant Steve Silverman
Steve Silverman, a former compliance director for the US FDA’s device center, gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation.
QMSR Quick Take: Attorney Dennis Gucciardo
Morgan Lewis partner Dennis Gucciardo gives a quick take on the US FDA’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation.