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.
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
The idea was born from a request he received five years ago from a friend, a retired physician who was suffering from post-polio syndrome: Anurag Purwar, a Research Associate Professor in the Department of Mechanical Engineering at Stony Brook University, has developed a device to help people with mobility issues raise themselves out of a chair more easily. Three Village Patch