Posts tagged risk management
Cybersecurity is the Next Frontier of Risk Management

As medical devices increasingly become more interconnected with other devices, hospital networks and even smartphones, cybersecurity risks are quite real. Managing these risks is a product life cycle issue because they are continually evolving and may arise due to circumstances not completely foreseen during their development. 

Read More
FDA Recognizes It's Time for QSR 2.0

FDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.

Well, it’s about time!

Read More
Achieving Excellence in Medical Device Benefit-Risk Assessments

Medical devices save lives, but they are not without risk. Whether it is a disposable soft contact lens used on a daily basis, or an intraocular lens surgically implanted to treat cataract, use of medical devices can potentially result in serious injury or even death. There are thousands of medical devices on the market, but there are also reports of millions of injuries and thousands of deaths associated with these devices in the last 10 years.

Read More
Regulatory Policy in the Age of Artificial Intelligence

Artificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.

Read More
The Real Goal of Medical Device Safety Surveillance

A defibrillator that locks-up after delivering the first shock causes delay in treatment which can result in serious injury or death. A needle-free closed system used to deliver chemotherapy drugs could release tiny plastic particles in a patient’s blood stream which can cause blockage. A pacemaker fails due to an unpredictable circuit error which can result in a life-threatening situation. These are just a few examples of Class 1 recalls recently announced by the FDA in a span of just a few weeks.

Read More