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.
Garmin notes that the use of wearables as health and medical tools is rapidly evolving and the company is “committed to the development of wearables that can lead to the detection of serious health conditions.” Read More
Improving analysis and data collection will require the development of common data elements for sex and gender to be included in some prominent medical device registries, said FDA Commissioner Scott Gottlieb. Read More