Call Us Today at 508-231-8842        EMERGENCY

PDF IconRisk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis

MEDIcept is presenting this as an ongoing series of articles focused on the conduct of risk management in the medical device industry. The intent of the series is to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, maintain compliance with risk management standards.

Our team at MEDIcept, plans to use these articles to capture best practices, explore the more challenging aspects of maintaining risk management systems over the long term, and elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know. 508-231-8842.

<a href=”” target=”_blank”><img class=”alignleft size-full wp-image-20″ title=”PDF Icon” src=”” alt=”PDF Icon” width=”18″ height=”18″ />Part 2 Risk Management White Paper D02</a>

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...