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Crisis Prevention and Recovery, LLC (dba SoftwareCPR®) consists of nine 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.
Brian Pate, Partner and General Manager, is the lead faculty for the AAMI/FDA course on Regulatory Requirements for Software Validation and teaches it annually in Washington DC. Brian has also taught this course on-site at FDA. Brian 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 (and continues to serve) of the AAMI/FDA Compliant Use of Agile Methods public course. Brian has also served as an instructor for the AAMI Design Controls course.
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served on the TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). Our partner, Sandy Hedberg, was a member of the member of ABRA/PPTA Information Systems Committee, PTAG (plasma technical advisory group) for ICCBBA, Information Data Management group with the HIMA software task force, and most recently served with the AAMI/FDA working group for a TIR on Medical Device Data Systems Compliance. Sandy has many years with regulatory and quality consulting and is expert with regulatory classification and submission.
SoftwareCPR® offers a full-service approach to assist your company with pre-market and post-market cybersecurity planning, evaluation, vulnerability and validation services. We combine experience with FDA expectations for analysis and control of cyber vulnerabilities with state-of-the-art and highly sophisticated methods and experience through our expert cybersecurity affiliate. We can support small medical device startups to multi-national corporations, low risk to high risk and simple to complex devices. Our approach is risk-based, using risk and threat analysis early in the process to help prevent late-cycle changes that are costly. Our cybersecurity affiliate currently holds a TOP SECRET clearance. Verification can be provided upon request (at time of contract negotiation) and PPI (protected personal information) will be submitted via separate coordination.
We can also support the entire human factors and usability engineering process. Our affiliate is a member of the AAMI Human Factors Engineering Committee, a member of Human Factors and Ergonomics Society, and HFES’s Healthcare Technical Group. She is a regular attender of the annual HFES Healthcare Symposia. In addition, she is PMP certified with certifications as Agile Certified Practitioner (PMI-ACP), Risk Management Professional (PMI-RMP), and Certified Usability Analyst (since 2008). Kathy can provide a full range of usability services ranging from assessments, strategic planning, study design, study execution, and creation of deliverables necessary for IEC 62366-1 compliance and FDA expectations. All nine partners are former practitioners – each was in the trenches at one time developing software products (or in the case of one of our partners, reviewing regulatory submissions at FDA). We have many years of experience – 30-year type folks. We can get to the core issues quickly and save you time and money. We often assist clients in defending their approaches to FDA during inspections or in response to enforcement actions or premarket submission deficiency letters.
We also maintain a 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. Our 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. Finally, we also can assist with larger scale agile transformation. We partner with Mike Russell, who specializes in corporate agile transformations, to ensure a tailored and efficient transformation that maintains solid compliance with global regulatory and national standards. You can view the credentials for all of the SoftwareCPR® partners at http://www.softwarecpr.com under the Credentials tab.
