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 Details
- Employees
- 16
- Founded
- -
- Address
- 15148 Springview St, Tampa,florida 33624,united States
- Phone
- +1-781-721-2921
- of****@****cpr.com
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- softwarecpr.com
- Keywords
- 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, IDE Submissions.
- HQ
- Tampa, Florida
Softwarecpr Questions
Softwarecpr's helpline number is +1-781-721-2921
Softwarecpr's website is softwarecpr.com
Softwarecpr's LinkedIn profile is https://www.linkedin.com/company/softwarecpr
Softwarecpr has
16 employees.
View email and phone details for 16
employees at Softwarecpr.
Softwarecpr's industry is
Medical Equipment Manufacturing
Softwarecpr's top competitors are
Williams & Stuart Real Estate,
Software Consultants Inc,
Ibs Digital,
Iotascale,
Pure Medical Equipment & Service,
Elucid,
College Of Alberta Dental Assistants,
Modern Launch,
Leading Spark,
Not The Mainstream.
Softwarecpr's support email address is office@softwarecpr.com
Softwarecpr's categories are Medical Equipment Manufacturing
Softwarecpr's founding year is 1999
