Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on…

Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Source: The…

The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to…

The FDA warned National Biological Corp. for failure to thoroughly investigate complaints and improper handling of out-of-spec products. Source: The GMP Letter

Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Source: The GMP Letter

The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of…

Companies will need to report within 48 hours from discovery if a medical device sold in Malaysia presents a serious threat to the public health according to new requirements released…

A new study of the four biggest makers of pacemaker systems found thousands of software vulnerabilities, highlighting an industry-wide problem with software security updates. Source: The GMP Letter

Both houses of Australia’s Parliament passed a new law to amend the Therapeutic Goods Act 1989 to enable certain variations that do not impact quality, safety or efficacy to be…

The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Source: The GMP Letter