Expert Consultation

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.

Partners and Staff

Alan Kusinitz
Founder

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.

Credential Sheet
John F. Murray, Jr.
Partner

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.

Credentials Sheet
Sherman Eagles
Partner

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.

Credential Sheet
Brian Pate
General Manager and Partner

Agile medical device software processes for FDA, TIR45 consultant, Software hazards analysis, risk management, TIR32 consultant, medical device verification and validation testing, coaching & mentoring.

Credential Sheet
Lucille Ferus
Partner

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.

Credential Sheet
Ron Baerg
Partner

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.

Credential Sheet
Raffaele Caliri
Partner

IEC62304 conformance assessment, software project management, software requirement analysis, software design, software V&V, software risk analysis, risk management, FDA software submissions.

Credential Sheet
Shawn Yang
Partner

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.

Credential Sheet
Jordan Pate
Validation Specialist

Test documentation and organization, manual and automated test development specializing on hardware and embedded software.

Amy Sellers
Legal Intern

2L Univ of Florida law student recognized as best oralist in Appellate Advocacy, with experience as an educator and in medical device quality systems and design controls.

Credentials Sheet

*Note: Partner is a title describing a branding and marketing partnership and does not indicate ownership or corporate structure.

 


Affiliated Experts

Greg Sandoe
Embedded Software Process and Methods
Credentials Sheet
Paul Felten
Test Engineer
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.
Read more
Credentials
Annette Hillring
Regulatory Affairs Expert
Credential Sheet
David Manalan
Regulatory Affairs and Quality Systems Expert
Credential Sheet
Stan Hamilton
Systems and Software Risk Analysis Expert
Credential Sheet
Jody Baudoin
Software Unit Verification Expert
Credential Sheet
Truc Le
Quality Systems and Management Expert
Credential Sheet

SoftwareCPR® MISSION

To foster greater margins of safety, effectiveness, compliance, and profit through better software risk management, acquisition, development, validation, and maintenance.