One of the most difficult challenges for medical device and HealthIT manufacturers is to properly "level" the design requirements for their medical device systems such that it is clear when it comes to design validation versus design verification.Read More
Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of...Read More
FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018. A few things to note related to software: On line 370, question 16, FDA addresses the question of the use of software...Read More
FDA issued a report entitled “REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018.” This report contains findings on five software functions excluded from the device definition by the 21st Century Cures Act. The FDA found these software functions have more benefits than risks to patient safety and health. The...Read More
Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.