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 FDAs 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...

Fda representation and negotiation,project and regulatory crisis recovery,fda software validation planning,21 cfr part 11 and general validation assessments,on-site and web-based training on part 11 and validation,and 510(k),pma,and ide submissions

Softwarecpr operates in the Medical equipment manufacturing industry.

Softwarecpr's revenue is 11m - 100m

Softwarecpr has 11 - 50 employees.