On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
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Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
Dr. Suzanne Schwartz, director of the FDA's Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health The Food and Drug Administration's decision to ...
ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it ...
Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and ...
Modern conveyance systems help medtech manufacturers achieve flexibility, compliance, and integration in smart factories.
WESTBROOK, ME—Systems integrator Lanco has been awarded a contract to design and build an automated, pallet-based test system ...
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