This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. A sample checklist for releasing or updating software is at the link provided. GoLiveiChecklistTrainingExample111115Read More
Brian Pate of SoftwareCPR® writes: In May 2014, FDA offered further guidance to manufacturers regarding premarket submission information identifying cyber-security risks and hazards associated with their medical devices, and the responsibility for engineering appropriate risk controls to address patient safety and assure proper device performance. FDA encouraged manufacturers to report any cyber-security incidents that may...Read More
Obviously, unit tests have their greatest value at the time of the development of the unit itself. Well-designed unit tests provide evidence that the unit performs its intended function, that the software design executes as intended, and allows the developer (or tester) to test the unit with inputs and states that may be difficult to...Read More
IEC/TR 62348 is a technical report that assesses “the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition.” The report is intended to be a tool for manufacturers to understand the impact of Amendment 1:2012 changes to 60601-1 from the...Read More
This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed. This example is modeled on the approach required by ISO 14971 and expands on it with...Read More
Although the HIPAA Privacy Rule directly effects “Covered Entities” medical device and pharmaceutical manufacturers may be involved in inadvertent release of private patient information and must deal with requirements from their customers that are Covered Entities. It was reported that: Eli Lilly, already has settled with eight states and the Federal Trade Commission for $160,000...Read More
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.