Softwarecpr
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- 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 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 FDAs 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.
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Headquarters:15148 Springview Street , Tampa, Florida, United States
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Phone Number: +1 781-721-2921
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Website: https://www.softwarecpr.com
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Employees:13
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Revenue:$1 - 10M
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Legal Name:Softwarecpr
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| NAICS Code: 332994 |
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Frequently Asked Questions regarding Softwarecpr
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Where are Softwarecpr's Headquarters?
Softwarecpr's Headquarters are in 15148 Springview Street ,Tampa,Florida,United States
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What is Softwarecpr's phone number?
Softwarecpr's phone number is +1 781-721-2921
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What is Softwarecpr's official website?
Softwarecpr's official website is https://www.softwarecpr.com
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What is Softwarecpr's Revenue?
Softwarecpr's revenue is $1 - 10M
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What is Softwarecpr's NAICS code?
Softwarecpr's NAICS code is 332994
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How many employees are working in Softwarecpr
Softwarecpr has 13 employees
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What is Softwarecpr's Industry?
Softwarecpr is in the industry of Medical Devices
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Who is Softwarecpr's Managing Partner?
Softwarecpr's Managing Partner is Alan