The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

The purpose of risk management is to create and protect value within the agency. Risk management refers to the steps taken by an agency to identify and manage risks which may impact their activities ...

ISO 31000 is an international standard for risk management that provides a framework for identifying, assessing, and managing risks across an organization.

Aside from real property disposal, the PDIC’s QMS in four other core services, together with their respective support processes, continued to be certified under ISO 9001:2015 standards. These core ...

When people rely on it regularly, it’s far less likely to become outdated. Adopting a modern, process-centric approach to compliance and risk management is like building a well-oiled machine.

This paper introduces ISO 14971 (Medical devices – Application of risk management to medical devices)'s role in medical device risk management, highlighting its integration with standards like ISO ...

Choose from Risk Management Process stock illustrations from iStock. Find high-quality royalty-free vector images that you won't find anywhere else.

Edwin L. Bills, RAC, ASQ Fellow, CQE, CQA, CMQ/OE, has been a member of ISO TC 210 JWG1 for more than 20 years. This is the ISO group responsible for medical device risk management and the creation ...