Information on FDA Software Validation, International Software Standards and Safety

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     A Medical Device, Pharmaceutical, and Blood Banking FDA Software Validation, Risk Management, Quality Systems and Submissions Part 11 Regulatory Reference Site and Consulting Company.

Bring our EN 62366 Course or our Software Standards (IEC 62304, IEC 80002-1 and others) FDA Compliance and Software Risk Management Course in-house.
Click Medical Device Software Standards Training  for more information. This course includes a module on a new FDA initiative in Safety Assurance Cases led by Sherman Eagles. SoftwareCPR®  now provides consulting support in development of Safety Cases.

     FDA's New Medical Device Data Systems classification rule 21 CFR Part 880 requires quality systems compliance for a wide range of software. At SoftwareCPR we can help those new to being FDA regulated design efficent approaches to compliance.

     FDA compliant use of Agile Methods for software development is an area where we also offer unique perspective, credentials, training materials and consulting support.

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

Email training@softwarecpr.com for On-site  training information on  IEC 62304, IEC 80002-1 and TIR32 by the chairs of the working groups that developed them. We also offer FDA compliance traiining and Risk Management Training.

 

 

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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Other offices in California, Florida, Minnesota, St. Thomas, Tennessee, Panama, Italy, and Washington D.C

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