RegDesk Regulatory Roundup

Jul 16, 2021

Health Canada Guidance on Risk Management for Medical Devices

Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported problems associated with medical devices. The latest version of the document...

ISO Introduces New Risk Management Standard

Dec 19, 2019

Uncategorized

ISO Introduces New Risk Management Standard

ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards ISO is an organization comprised of several national standards bodies. The...