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 (