If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to ...

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

Risk management involves a three-step procedure: hazard identification, risk assessment, and risk mitigation in case of unacceptable risk levels. In fact, the hazard identification process should ...

Vanta reports that SaaS companies increasingly pursue ISO 27001 certification to enhance security and build trust with ...

Formal risk assessment methodologies can help take guesswork out of evaluating IT risks if applied appropriately. Here are six to consider. Technology is one of the greatest assets companies have, ...