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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.
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SERVICES
SOFTWARE REFERENCE
CCOMMUNICATE
Overview Credentials Leave message Training Assessments Code Inspection Give Feedback Submissions Risk Mgmt & Safety Cases Design Tools Crisis Recovery 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.
Site Information
781-240-8570 (fax)
20 Berkshire Drive Winchester, MA 01890 USA
Other offices in California, Florida, Minnesota, St. Thomas, Tennessee, Panama, Italy, and Washington D.C
Copyright 2010 Crisis Prevention and Recovery, LLC
SoftwareCPR® is a registered trademark of Crisis Prevention and Recovery, LLC