Category: Medical Devices

The pharmaceutical, biotechnology, and medical device industries are highly regulated, with strict guidelines to ensure the safety, efficacy, and quality of products. One such regulation is 21 CFR Part 11, issued by the U.S. Food and Drug Administration (FDA). 21 CFR Part 11 sets forth the requirements for electronic records and electronic signatures, aiming to […]

ISO 14971 is an international standard that provides a framework for the risk management of medical devices. The standard defines the requirements for risk management and provides a framework for assessing and controlling safety risks associated with medical devices. ISO 14971 is widely adopted, and compliance is mandatory in many regions. Today, there are three […]