The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
LEESBURG, Va.--(BUSINESS WIRE)--Stryker (NYSE:SYK), one of the world’s leading medical technology companies, announced that Early Product Surveillance (EPS) cases utilizing its Q Guidance System with ...