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The European Commission released guidance on qualifying software under the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read More
Governments and standards organizations worldwide are moving toward a healthcare delivery system where devices work together, but devicemakers may need better incentives to get on board, an analyst says. Read More
Developers of medical device software should use secure coding standards that address known memory access vulnerabilities to protect their products from hacking, a new report says. Read More
The International Medical Device Regulators Forum has issued a proposed document explaining how to use quality management systems to regulate software as a medical device. Read More
Manufacturers of general wellness products wondering how the U.S. FDA might regulate their goods should check how the agency deals with similar devices, an attorney says. Read More