SoftwareCPR

Crisis Prevention and Recovery LLC (dba SoftwareCPR®) is a general purpose regulatory consulting firm partners specializing in FDA regulation, representation, and negotiation for medical device, pharmaceutical, and biologics manufacturers. SoftwareCPR® partners participate in standards and software policy development as well as training with FDA’s internal software experts. Each day our partners provide consulting services related to quality systems compliance, MDR reporting, premarket submissions, design control, risk analysis, software validation, recalls, cybersecurity, human factors/usability, 21 CFR Part 11, project management, and process improvement. SoftwareCPR® also provides a software regulatory information and educational subscription service at www.softwarecpr.com with newsletters, procedural, document, and checklist examples, training aids and reference manuals.
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.
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 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 and will lead the course again in 2017.

Company’s Keywords:

fda representation & negotiation, project & regulatory crisis recovery, fda software validation planning, 21 cfr part 11 & general validation assessments, onsite & webbased training on part 11 & validation, 510, pma, ide submissions