Our risk management course focuses on the software risk management process based on ISO 14971 device as an input, IEC 62304 risk management requirements, and guidance for software found in IEC/TR 80002-1, both which are consensus standards with US FDA.
As with all SoftwareCPR® courses, our approach is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Our training covers regulatory, quality, and the details of the software development process necessary for compliance.
Our standard format course covers the topics listed below:
§ Brief Regulatory Background – US FDA, EU
§ SOUP, OTSS, and Legacy Software
§ 62304 Safety Classifications vs. FDA LOC
§ Harms – Direct & Indirect, Hazards, Hazardous Situations
§ System, Device, Product level considerations – 60601-1, 82304
§ Identifying Causes and Causal Pathways, Failure Modes
§ Probability and Severity related to software
§ Risk Control – Design, Architecture
§ Risk Control Effectiveness
§ Verification and testing
§ Managing Risk after release
§ Risk Control - Process
§ Documentation, Traceability, Electronic records
§ Tailored Cybersecurity vulnerability analysis, cyber controls, validation § Use Error and Human Factors Engineering
Workshops and exercises integrated throughout teaching modules.
Email firstname.lastname@example.org for more information.
- Jan 9-11, 2023 in Tampa, FL
- 3 days, 8:00 am to 5:00 pm EDT each day
- CAMLS - Center For Advanced Medical Learning And Simulation
124 South Franklin Street | Tampa, Florida 33602
- Brian Pate - Partner and General Manager at SoftwareCPR®
- Dr Peter Rech - Partner at SoftwareCPR®
Brian Pate taught the AAMI/FDA course on Software Regulation to FDA Reviewers publicly in DC for over 10 years and has taught the course at FDA. Brian served on the TIR working group that created the AAMI TIR32-2008 (later became IEC/TR 80002-1) for software risk management, and TIR45-2012 Guidance on the use of Agile practices in the development of medical device software and is a reviewer for the 2nd edition of TIR45. Brian currently serves as faculty for the AAMI/FDA Compliant Use of Agile Methods public course and also has served as an instructor for the AAMI Design Controls course. Brian is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel 5500, Remote Software Updates.
Dr Peter Rech has over 20 years’ experience in systems and safety engineering in regulated industries in individual contributor and management roles. He has worked with Class II and III medical devices including implantable pacemakers, infusion pumps, and remote monitoring devices and apps. He held certificates as INCOSE Certified Systems Engineering Professional and TUV Rheinland Certified Functional Safety Engineer. He holds a Doctor of Philosophy (PhD), Physical Chemistry, Free University Berlin, and speaks English, German, and French.