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Medical Device,
Pharmaceutical, and
Blood Banking
FDA Software Validation, Risk
Management, and
Part 11 Regulatory Reference
Site.
SoftwareCPR® helped develop and offers training
in IEC 62304 Medical Device Software - software lifecycle
processes, an FDA recognized and now EU harmonized standard also
being adopted by the Chinese SFDA.
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SOFTWARE REFERENCE
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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
Email training@softwarecpr.com for On-site FDA training or information on training on IEC 62304 and risk management using 80002-1 and TIR32 by the chairs of the working groups that developed them.
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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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