The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity principles and practices.” Read More
The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device within certain FDA-recognized standards. Read More