We now offer fast (1-2 weeks) fixed price development tool validations for JIRA, SVN, Git, DataGrip, Microsoft(R) Visual Studio, Apple(R) Xcode, and others. Call 781-721-2921 or email Brian Pate (firstname.lastname@example.org ) today for more information.
We provide full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on quality system automation and medical device validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation.
We also provide Design History File and Software Validation REMEDIATION to create or improve essential documentation and testing.
SoftwareCPR® Partners have played key roles in development of FDA recognized standards for Medical Device Software and Risk Management, Health IT, authored publications referenced in FDA guidance documents, and provided internal training to FDA and Health Canada, served as instructors for AAMI/FDA courses on the Quality System Regulation , Design Control, Software Regulation, Agile Methods Compliance, and Safety Assurance Cases.
Mobile Apps (MApps) and Mobile Medical Apps (MMApps) that may be regulated as medical devices present unique risk management, quality and compliance challenges. SoftwareCPR® is uniquely qualified to support efficient Mobile App risk management, V&V and compliance activities.
Other of specialization are compliant use of Agile Methods, development of Safety Assurance Cases, & independent risk based design, code inspections and static analysis.
Software Regulatory and Safety News.
SoftwareCPR®'s archive of software and computer related FDA warning letters.
SoftwareCPR®'s archive of software and computer related FDA recalls.
Conferences and public courses related to software regulation and standards.
Wide range of software related documents and educational information.
Partial list of topics and selected documents and Standards Navigator
Links to some of the most popular documents.
Brian Pate's SoftwareCPR® Twitter Feed.