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.
Software & Quality Systems regulatory crisis management and FDA negotiations including recovery from import detentions, injunctions, consent decree negotiation, requests for consultant certifications, warning letter responses, and more.
John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.
Medical device software standards expert, IEC 62304 and IEC 60601-1 PEMS chairman, IEC 80002-1 medical device software risk management, IEC 80001-1, safety cases.
Agile medical device software processes for FDA, TIR45 consultant, Software hazards analysis, risk management, TIR32 consultant, medical device verification and validation testing, coaching & mentoring.
Assessments/ implementation of least burdensome FDA/ISO13485 compliant QMS, design controls, SDLC. IEC62304 process; software risk management; TIR 32 committee member. Drafting software submission information.
23 years experience in medical device software development and management focused on large, complex systems with multiple computing systems containing all safety classes of software.
IEC62304 conformance assessment, software project management, software requirement analysis, software design, software V&V, software risk analysis, risk management, FDA software submissions.
Mike is an expert in business agility and is key to our “agile and compliant” process transformation and improvements. Mike served on the TIR working group that created the AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software. Mike combines experience serving as both a C-level executive, including as Chief Operations Officer for a top 60 U.S. bank, and as a trusted advisor to CEOs and other top executives at diverse organizations in multiple industries. This has provided him with first-hand experience dealing with many opportunities and challenges facing executives today, especially with rapid change and digital transformation. For example, while leading a product division, Mike introduced changes that resulted in improved productivity by 15%, cut time-to-market by up to 67%, and reduced defects by over 50% in flagship products processing of over $80 billion in financial transactions per year.
Ginny is a regulatory affairs professional specializing in software-based products starting in 2011. She has experience in the regulated industry including medical devices, pharmaceuticals and biotechnology.
Ginny has developed regulatory strategies for a variety of SiMD/SaMD and AI/ML-based products during her career at start-ups, mid-size companies and global enterprises. She has worked on US regulatory submissions including Q-Sub, 510(k) and PMA and has supported a variety of global submissions. Ginny is known for both strategic and tactical support including hands-on, close collaboration with frequent-release agile development teams. Ginny’s professional objectives are driven by her personal goal to expedite the development and approval of quality medical products into medical markets.
Risk based code review and real-time embedded software analysis of medical device. IEC62304 software requirement, design, V&V testing processes for FDA, ISO14971 risk management.
Test documentation and organization, manual and automated test development specializing on hardware and embedded software.
University of Florida Levin College of Law graduate with experience as an educator and in regulatory affairs, medical device quality systems, and design controls.
*Note: Partner is a title describing a branding and marketing partnership and does not indicate ownership or corporate structure.
Anette has been a regulatory affairs consultant since 1998. Prior to consulting, she was Director, Regulatory Affairs, for Critikon, a Johnson & Johnson Company, where she worked with cardiovascular monitoring devices. She has over 25 years experience in regulatory affairs, compliance and clinical affairs with prior experiences in the implantable cardiovascular and ophthalmic devices industries. Her worldwide regulatory affairs responsibilities have included FDA submissions, GMP/QS compliance, interpretation of all FDA regulations and policies, regulatory representation on new product development teams, product liability and international product registrations. She has also represented Johnson & Johnson on several software related FDA/industry guidance and standards-setting activities.
Annette is Regulatory Affairs Certified and holds BA degrees in biology, microbiology and secondary science education.
Forward-thinking Engineering professional with 20+ years’ achievement directing and participating in complex product development lifecycles. Diligent technology strategist with successful track record producing high-impact instrument designs. Effective strategist with successful track record producing devices that incorporate the latest and advanced technologies. Experience driving compliance to standards. Uniquely adept at establishing and maintaining strategic partnerships with consultants, vendors, management, and other stakeholders to grow and maintain quality designs.
Stan helps medical device companies achieve high-quality, risk-mitigated, regulatory compliant, and clinically valued software. He began his career as a design engineer on state-of-the-art avionics programs such as the Advanced Tactical Fighter, but soon transitioned to hardware/software design engineering in the medical device industry where he has over 25 years of direct safety and regulatory engineering experience. He spent several years at Johnson & Johnson, and then Baxter Healthcare, where he managed groups that performed safety, quality, and regulatory engineering (including risk management, validation, qualification testing). His risk management expertise includes system, software, use error, and cybersecurity.
Tom has spent over 25 years developing medical device and commercial software systems. Tom was on the front end of server-based web applications serving many commercial sectors and helped many of his clients enter the mobile-cloud platform world.
Gwen has spent the last ten years in and around medical devices involved in programming, testing, and system level failure modes analysis. A medical physicist by training, Gwen brings a wealth of knowledge and expertise to our cybersecurity evaluation services.
Highly skilled in program/project management and has spent a 40+ year career managing very complex projects in safety critical and medical device industry. Bob brings order, stability, and predictability to a wide variety of situations.
Software requirements review, creation and remediation. Test documentation, manual and automated test development, and test execution. Software validation as it relates to 21CFR820, 21CFR820.70(i), 21CFR820 Part 11, and IEC 62304.
Bob has spent over 25 years developing custom medical devices and commercial electro-mechanical systems. Bob can make the system relationship to the software, electronics, mechanics, fluidics, and optics crystal clear! He is very skilled at planning overall verification strategy and approach and managing the overall evolution of the DHF.
SoftwareCPR® MISSION
To foster greater margins of safety, effectiveness, compliance, and profit through better software risk management, acquisition, development, validation, and maintenance.
