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SoftwareCPR^® Partners have played key roles in development of FDA recognized standards for Medical Device Software, authored publications referenced in FDA guidance documents, and provided internal training to FDA and Health Canada on Software Validation and Risk Management.

SoftwareCPR^® can provide full service regulatory compliance support for Medical Device Manufacturers including quality systems development, submissions, risk management and technical files as well as validation services for Pharmaceutical companies.  Training and consulting can also be provided in Chinese, Italian, and Spanish

AAMI/IEC 62304 Medice Device Software - software lifecycle processes and AAMI:TIR32 Medical Device Software Risk Management Report can be ordered by sending email to standards@softwarecpr.com.

This TIR32 report has information that would be useful for software safety in other industries as well as medical  including avionics, automotive, military, and nuclear.

Email training@softwarecpr.com for On-site and web based training information on  62304 and TIR32 by the chairs of the working groups that developed them.

 

 

Join our Mailing List to receive free occasional email updates on FDA software regulation news.

 

The purpose of this website and the company's mission is to help improve the safety, effectiveness, validation, and compliance of medical products with efficient and effective risk-based approaches.

 

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Alan Kusinitz
Managing Partner

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781-721-2921

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