Newsletter | December 7, 2024

12.07.24 -- Nobember's Most Popular Articles & Solutions

FEATURED EDITORIAL

A New Approach To ISO 14971 For Better Medical Device Risk Analysis

This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

Computer Systems Validation Pitfalls, Part 2

In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

FDA Oversight In AI-Enabled Medical Device Manufacturers

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare to navigate new legal challenges.

TOP INDUSTRY INSIGHTS

Align Your Medical Device With Human Factors Industry Best Practices

Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

How Sensor-Enabled Catheters Are Driving Healthcare Innovations

Sensor technologies embedded in catheters are enhancing surgical precision and real-time monitoring capabilities. Explore how these innovations are reshaping medical procedures and patient outcomes.

Reduce Human Error In Healthcare Operations

Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care.

TOP RESOURCES

Medical Stopcocks: Divert Series

Respiratory Products For Diagnostics And Therapeutics

Delays To Market In Generic Drug Manufacture Can Be Costly

Connect With Med Device Online: