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.
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
Medtronic Navigation of Louisville, Colo., received an FDA Form 483 for issues related to design validation, process validation, CAPAs, acceptance activities and nonconforming product. Read More
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More