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, Non-Product Software (CSV, QS, Manf/process, Tools), Quality System Regulation, Design Control, Software Regulation and international medical device, Usability, and HealthIT Standards.
Our instructors understand regulatory agency expectations and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA terms. Our instructors have been in involved in software standards development including IEC 62304, AAMI SW68, AAMI TIR32, IEC 60601-1 PEMS, UL 1998, IEC 80001, AAMI TIR45, and IEC 80002 and can train your staff in pragmatic and efficient methods of conformance to standards.
Our training can be tailored to your needs, your products, your regulatory perspective, and your business objectives. Our training includes FDA enforcement examples, key FDA guidance, electronic, checklists, and other educational aides.
We offer both awareness and skills training. Awareness training courses provide short overviews of key concepts and requirements ranging from 2-hour executive overviews to one-day introductory courses. Skills training courses are generally multi-day and are highly interactive using short exercises, formal workshops, and free form and structured instructional Q&A.
Fully customized courses integrating customer policies and procedures are prepared on request and can be integrated into internal company training programs or produced as self-study computer-based training modules.
The FDA General Principles of Software Validation guidance states “Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR 820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.”
Our Quality System Software Validation (QSS) course focuses on software that requires validation activities and documentation that is not contained or operated in the medical device. This includes topics such as:
Quality System Process Automation and Records Management software
ERP, Complaint Handling, CAPA systems, Computer System Validation, etc.
Manufacturing and/or production Process Automation software
Manufacturing and/or production Quality Control software
Measurement systems, Calibration, spreadsheets, etc.
Engineering and Validation tools software
Our 3-day QSS course is typically offered publicly every year and can be provided onsite many times throughout the year. We use our expert knowledge of the regulations and standards, to provide detailed examples and insight of smartly applying methods and strategies to ensure quality and minimize inspection risks. We cover the use of process mapping and critical control points analysis to develop efficient methods of QSS validation.
This course helps the student understand how Medical Device, Medical Mobile App, and HealthIT Software can be developed using agile methods and meet the FDA expectations for medical device software and be compliant with IEC 62304. The course is framed around IEC 62304 and how the standard can be used to ensure agile methods and approaches to software development will include the proper activities and deliverables for safe and effective software. The course uses concepts from AAMI TIR45 to help communicate how agile methods can, when used properly, improve software quality. The course also references US regulations and FDA guidance to address potential gaps that can occur with agile methods when one doesn’t consider the all important user need of “safety”.
This course can be tailored to SaMD, small embedded systems, or large and complex systems. This 3-day course integrates exercises and workshops.
This 2-day course has two parts: Day 1 is an overview of basic information security related to PHI and PPI using ISO ISO 27799:2016 Health informatics and AAMI TIR57, including expectations for pre-market submissions. Day 2 focuses on client specific workflows, vulnerability analysis, and cyber and physical risk controls. Day 2 can be setup as more of a workshop for organizations lacking detailed policy and procedures in this area.
This 3-day software risk management course is a very intensive and immersive into the application of IEC 80002-1. The course is highly exercise and workshop oriented and can be tailored to client products or sub-systems. Students will come away fully confident in how to perform software risk analysis and understand the concepts of ISO 14971, IEC 8002-1, and the software risk management requirements of IEC 62304 AMD1:2015.
Ask how these courses can be customized for your products and processes:
Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software. Planning, requirements, validation, and submissions – we can assist with all.
Interested in having a conversation? Email us to arrange a Zoom meeting or call us at +1 781-721-2921.