Crisis Prevention and Recovery LLC does business as SoftwareCPR®. SoftwareCPR® consists of several partners who are experts in FDA regulation (and ISO standards) in general, and medical device software in particular. Most of our partners and affiliates are former practitioners – they were in the trenches at one time developing and/or qualifying medical devices and the software associated with those products. Our experience ranges from deeply embedded software to SaMD running on standard platforms, from complex control algorithms to user interface graphical software, and from the test lab to the executive board room. We have many years of experience – most of our partners have been in this industry for over 30 years! Well seasoned we like to say.
We can get to the core issues quickly and save you time and money. We do not use a one-size-fits-all approach – we seek first to understand our clients’ culture, what makes their products unique, and how quality assurance already exists in their DNA. Our support can range from strategic advice on regulatory classification to full hands-on remediation of any quality system documentation or records. We even can provide many types of design verification and usability evaluations.
SoftwareCPR® is best known for software, regulatory, risk management, validation, and 21 CFR Part 11 consultation for medical device, pharmaceutical, and blood establishment computer system manufacturers. We also provide full FDA enforcement action crisis recovery, premarket submission, and quality system training and consulting services with a focus on client culture, business goals, and efficiency as well as device safety and effectiveness.
SoftwareCPR® has provided internal Software Validation and Risk Management Training to FDA and Health Canada and SoftwareCPR® partners frequently teach with FDA co-instructors.
Individual credential PDF files can be downloaded by clicking on the photos and/or the link icon.
*Note: Partner is a title describing a branding and marketing partnership and does not indicate ownership or corporate structure.
To foster greater margins of safety, effectiveness, compliance, and profit through better software risk management, acquisition, development, validation, and maintenance.