Credentials

SoftwareCPR®; is best known in software, regulatory, risk management, validation, and 21 CFR Part 11 consulting 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.

PARTNERS

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 others...

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Brian Pate
General Manager

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

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Affilated Experts

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

SoftwareCPR® Mission

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