Call Us Today at 508-231-8842        EMERGENCY

PDF IconMedical Device Risk Management Series – Part 2: Prioritizing Risk Management Activities

This second article in our series addresses a common risk analysis problem – prioritization.

In large medical device companies, the email invitation to a Failure Mode and Effect Analysis (FMEA) risk management session can strike fear (or at least dread) into the hearts of engineers and other members of the risk management team. One reason that they may not be eager to click “Accept” is that these sessions can quickly devolve into detailed investigations of issues of negligible severity or probability of occurrence that soak up the team’s time and energy – to the point that important issues may not receive the attention they deserve.

Small medical device companies, without a mature product line or risk management system, may have the opposite problem. There, the list of hazards being considered may be limited to those issues that are most obvious to the design team and may not provide a comprehensive assessment of device risks. Instead of an overly detailed analysis, these companies run the risk of not going deep enough.

This article provides an introduction to approaches that device companies have successfully implemented to focus their risk management activities and help to ensure the safety and efficacy of their products.

Sign up to receive our Newsletters!

The Latest News

Artificial Intelligence: What you need to know about next-gen smart medical device compliance

Recent strides in artificial intelligence (AI) and machine learning technology is opening the door to the development of increasingly smart medical devices capable of turning big data and digital information into actionable insights for healthcare professionals. AI is having a significant impact on the evolution of smart devices and how healthcare will be delivered in the future. AI, coupled with machine learning, is calling into question what it means to approve a medical device capable of...

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions. It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the...

Digital Health Innovation and Regulatory Compliance

Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some...