Course based and framed around 62304 but will address the following aspects as they relate to the 62304 process:
- Impact of agile methods to 62304 compliance
- Amendment 1 changes to 62304 (changes to risk and dealing with legacy software)
- IEC 62366-1 formative and summative usability/human factors for validation
- Software risk management guidance from 80002-1
- IEC 82304 for Health IT and standalone software
- Cybersecurity planning, evaluation, and validation
- Discussion on the upcoming 2nd edition of 62304
- Discussion on how privacy requirements (e.g., HIPAA) might intersect with risk management activities
- Other relevant medical standards for networking safety
Workshops and exercises integrated throughout teaching modules.
Email firstname.lastname@example.org for more information.
- Jan 24-26, 2018 in Sunnyvale, CA
- 3 days, 8:30 am to 5 pm each day
- The Domain Hotel, 1085 E El Camino Real, Sunnyvale, CA 94087 (Book Now!)
- Alan Kusinitz - Founding Partner at SoftwareCPR®
- Brian Pate - Partner and General Manager at SoftwareCPR®
Crisis Prevention and Recovery LLC dba SoftwareCPR® consists of ten partners who are experts in FDA regulation (and EU certs) in general, and medical device software in particular. Alan Kusinitz, our founding partner, has provided training internally for FDA and Health Canada, and is the developer of the AAMI/FDA course on Software Regulation, which he taught for many years with FDA’s internal experts. He has also taught the AAMI courses on the Quality System Regulation as well as Safety Assurance Cases. Alan and Brian Pate recently taught the AAMI/FDA course on Software Regulation to FDA Reviewers in July 2014 and a public course in May 2015. Brian was the lead faculty for the Software Regulation course in March 2016 in Baltimore.
Brian recently served on the TIR working group that created the AAMI TIR45-2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software. This group was privileged to have FDA staff participate with the group providing FDA input to the TIR on these practices. Brian has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course, and will be teaching the class again in 2016. Brian also served as an instructor for the AAMI Design Controls course in Baltimore in March 2015.
Our partner, Sherman Eagles, was the convener of IEC/ISO joint working group that developed IEC 62304 Medical device software life cycle processes and IEC 80002-1 Guidance on the application of ISO 14971 to software. Additionally, Sherman was the convener for the working group that added the software requirements to the 3rd edition of 60601. He was also a member of the working group that inserted risk management throughout the 3rd edition. As a convener, he was a member of the chairman’s advisory group that oversaw the development of the 3rd edition. As such, Sherman has been part of training that the 3rd edition team did in Paris, Frankfurt and Washington.
Partners Lucille Ferus, Alan, Sherman, and Brian (Alan was co-chair) also served on the TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1).
SoftwareCPR® also maintains a small software verification and validation group that can provide a variety of V&V services ranging from hands-on V&V testing, test protocol development, mentoring V&V staff, or automated test development. Paul Felten and his staff can "jump start" your team to quickly get IEC 62304 / IEC 82304 compliant V&V processes and test procedures in place, and then transition to your team, or we can continue to provide verification test support on an on-going basis. We specialize in strategic automated test development using tools such as Ranorex® (we are a Ranorex® Silver Partner) that can greatly increase test coverage, minimize regression errors, and improve time to market. We can also provide automated testing using Python-based approaches or custom setups for embedded systems.
You can view the credentials for all of the SoftwareCPR® partners at http://www.softwarecpr.com under the Credentials tab.