2 Page  brochure               About the Company       SoftwareCPR Approach 

SoftwareCPR® specializes in software, regulatory, risk management, validation, and 21 CFR Part 11 consulting for medical device, pharmaceutical, and biologics manufacturers. We also provide full premarket submission and quality system training and consulting services. 

SoftwareCPR® periodically provides internal Software Validation and Risk Management Training to FDA and Health Canada.

We provide strategic advice, regulatory risk management and negotiation, facilitation, , training, coaching, and hands-on assistance including in software validation. 

 

Partners and Associates

Managing Partner:

                                                     Alan Kusinitz  (click names for credentials sheets)

Partners* & Associates: 

         Stan Hamilton                                  Sherman Eagles                    Mary Decareau                   

                        

Lucille Ferus                                     Sandy Hedberg                            Molly Ray         

                           

Jeff Wallace                              Brian Pate 
               

                                                                                                                 
    Raffaele Caliri                             Shawn Yang

                                             

Annette Hillring

Truc Le

David Manalan 

 Robert Martin

Poul Schmidt-Andersen 

Ron Eisenwinter

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 title describing a branding and marketing partnership and does not indicate ownership or corporate structure.

 

20 Berkshire Drive Winchester, MA 01890 USA
Telephone (781) 721-2921
Fax (781)-240-8570
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