Product Development & Management Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions by Jama Software
Product Development & Management FDA Releases New Guidance on Cybersecurity for Medical Device by Jama Software
Requirements & Requirements Management Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management by Michelle Wu
Cybersecurity 2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability by Decoteau Wilkerson
Requirements & Requirements Management Complying with FDA Design Control Requirements Using Requirements Management Principles by Jama Software
Compliance & Regulation Five Key Design Control Practices that Improve Compliance and Help Develop Better Products by Mercedes Massana
Software Development Software as a Medical Device (SaMD): Four Key Development Best Practices by Mercedes Massana
Compliance & Regulation How the FDA’s New Safety and Performance Based Pathway Could Affect Medical Device Development by Jama Software
Customer Spotlight A Developing Story: Elucent Medical Began Developing Surgical Tools with Jama Connect™ in Less Than a Week by Eira Long May
