We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read More
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing. Read More
The FDA released draft guidance for devicemakers on 510(k) submissions for catheter-based devices intended to treat peripheral vasculature lesions, including suggestions on labeling and performance testing. Read More
The FDA cited six devicemakers for a range of GMP and other failures, including root-cause analysis for nonconforming products and lax environmental controls. Read More
