2 Page brochure About the Company SoftwareCPR Approach
SoftwareCPR® specializes in software regulatory, management, validation, Part 11, and HIPAA consulting for medical device, pharmaceutical, and biologics manufacturers.
SoftwareCPR® staff provided internal Software Validation and Risk Management Training to FDA and Health Canada in 2004.
Our expertise includes all aspects of regulatory affairs and quality systems for medical devices as well as general engineering management and design control in addition to software related services.
We provide advice, regulatory risk analysis, facilitation, negotiation, training, coaching, and hands-on assistance.
Partners and Associates
Managing Partner:
Alan Kusinitz (click names for credentials sheets)
Partners* & Associates:
Stan Hamilton (as of 1-Jul-08) Mary Decareau
Lucille Ferus Sandy Hedberg Molly Ray
Jeff Wallace Brian Pate Bob West
SoftwareCPR® Mission
To foster greater margins of safety, effectiveness, compliance, and profit through better software risk management, acquisition, development, validation, and maintenance.
*Note: Partner is a job title and does not indicate corporate structure for tax purposes or liability.
Copyright Ó 2001 Crisis Prevention and Recovery, LLC