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.
Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group.
Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More
With five new medical device regulations set to take effect in China on Oct. 1, industry insiders are worried the short transition period will affect supply of products in the country. Read More