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80002-1
IEC 80002-1 “Guidance on the application of ISO 14971 to medical device software” has been reconfirmed with a new stability date of 2016. This means that the document will not change before 2016. The next review to determine if the technical report should be revised will occur in 2015. IEC 80001-1 “Application of risk management...
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“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...
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IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software Course Dates: TBD COST: 3 Full Days for $2,400.00 (Fully transferable at any time.) This course focuses on ensuring the participants are aware of the relevant standards and US regulations that drive the processes for creating medical device and HealthIT software, and the...
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The U.S. Food and Drug Administration (FDA) announced today that AAMI SW96 Receives FDA Consensus Standard status.  Medical device manufacturers are now expected to conform to the requirements of this standard as applicable, or have processes that show address the requirements of the standard. The broad outline of AAMI SW96 is: General requirements for security...
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ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective Public Training Course DATES:  Jan 9-11, 2023 Includes “how to” for application of IEC 62304 for software risk management! COST: 3 Full Days for $2,995 DISCOUNTS: 3 or more students from same company: 10% discount (off full registration) November 2022 Early Registration:  $2,395 Register at...
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An excellent overview of the challenges and benefits of the Microservices architectural style of software application development.  While many of the factors discussed by the author (Dr. André Fachat, published January 30, 2019), these same factors can affect the safety and efficacy of a medical devices using this style.  The article consists of two parts:...
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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...
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As more “software as a medical device” (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with the rise of SaMD has come the emergence of supporting organizational, management, and production activities that...
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What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  The topics we plan to cover in our 2019 course are below. Topics: Regulatory...
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FDA posted a Stryker announcement today that the company is launching a voluntary field action (VFA) on specific units of the LIFEPAK 15 Monitor/Defibrillators. The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as...
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Does FDA accept regulatory submissions for medical devices and SaMD that have software developed using agile methods? What about IEC 62304 compliance?  Can agile and lean approaches to software development be compliant? On February 18th and 19th, 2019, we will explore those topics and more at our 2019 “Being Agile & Compliant” public training course. ...
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“[W]e have received a very nice letter from the FDA indicating that they have ‘determined the device substantially equivalent to the legally marketed device…’. Needless to say we are very happy with that. Thanks so much for you help and insight. You’ve made a great difference for us.” Yves Theriault Project Manager / Gestionnaire de...
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The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems.  The idea is that the Verily watch would be worn similar (or as!) a consumer device...
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62304 Training Course Overview Our flagship three-day 62304 training course provides a clear understanding of the 62304 standard for medical device software and much more.  With this training, participants will compare and contrast 62304 with FDA expectations.  Ample time is provided for discussing approaches for alignment between 62304 and FDA expectations.  Additionally, participants will learn...
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Glanced through the latest FDA warning letters today.  From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.”   Of course this is...
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Instructors for internal FDA software validation training and lead instructors for public AAMI/FDA Software Regulation Training courses, Alan Kusinitz, SoftwareCPR®’s Founder and Brian Pate develop and coordinate SoftwareCPR® training courses on IEC 62304/FDA Software Process, Quality System Software (CSV, QS, Manf/process, Engineering Tools), Quality System Regulation, Design Control, Software Regulation and international medical device, Usability, and...
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We provide high impact regulatory compliance and premarket submissions services to Medical Device Manufacturers including: Submission readiness reviews Mock FDA inspections Quality management system audits and assessments IEC 62304 software lifecycle process assessments (including SiMD, SaMD, and HealthIT) ISO 14971 risk management process assessments IEC 62366 usability engineering process assessments Cybersecurity pre-market and post-market process assessments Software...
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FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.”  This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review.  It...
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This update addresses International and US National medical device standards (“a view of the landscape”) being developed or revised that may be of interest to developers of software for medical devices or healthcare. Some of these standards are used directly for regulatory purposes and others may be valuable in demonstrating to regulatory authorities that a...
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Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®: Cybersecurity vulnerabilities can have unpredictable effects on safety.  Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar.  That concept is explained in relation to...
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These two draft standards for networked medical devices and for medical device software risk management have been renumbered IEC 80001-1 and IEC 80002-1 respectively. IEC 80002-1 was released for a 3 month ballot period Jan 16, 2009.
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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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