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Remember the 2005 guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices? In 2020 that guidance is as relevant as ever, and it can be useful to review what we know about the FDA’s expectations regarding Level of Concern (LOC) in medical devices. LOC is important if for no...Read More

Do you understand the Q-Sub Guidance? The FDA issued the guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program in 2019, but it has taken some time for the industry to understand all the facets of the program. The guidance covers a wide range of FDA submissions – IDE/PMA/HDE applications, de novo...Read More

“Agile” remains a hot topic in general, and “compliant agile” is a goal in many medical (and other regulated) companies. However, “agile” also remains difficult and elusive for many. This article will examine one of the most common hurdles to achieving agile benefits from well-intentioned initiatives. First, let’s address agile and medical device development in...Read More

This July 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...Read More

This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. What is a Real-Time PMA Supplement? Section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act defines a Real-Time PMA Supplement as: “a supplement to an approved premarket application or premarket report under section 515 that requests a...Read More

This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier.  Just the name itself, corrective and preventive action, describes one of the...Read More

This February 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...Read More

This "FDA GPSV Traceability Expectations" post is only available to Premium subscribers. See our Subscribe page for information on subscriptions. Going way back to the late 1990's, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness...Read More

This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date...Read More

ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...Read More