SUBSCRIBER LOGIN SUBSCRIPTION INFORMATION
A 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 and
IEC 80002-1 Medical Device Software Risk Management.
Our next
public training on these and related standards is Nov 9-11 near Boston,
MA Just click Registration
Information . There
are significant early registration discounts.
SERVICES
SOFTWARE REFERENCE
CCOMMUNICATE
Overview Credentials Leave message Training Assessments Code Inspection Give Feedback Submissions Risk Analysis Design Tools Project Mgmt 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.
Legal Notice and Privacy Policy
Site Information Managing Partner message781-240-8570 (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