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.
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 inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
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. Read More
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 current device GMPs, packaging and labeling rules, and regulations on intended use. Read More
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 the new approach is to determine whether a company meets the necessary quality standard. Read More
Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Read More
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 by Malaysia’s Medical Device Authority. Read More
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. Read More
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 made by notification to the Therapeutic Goods Administration. Read More
How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans? Read More