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 validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.
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 on Software Validation and Risk Management and served as instructors for AAMI/FDA courses on the Quality System Regulation , Design Control, Software Regulation, Agile Methods Compliance, Safety Assurance Cases, and Supply Chain Management.
Mobile Apps (MApps) and Mobile Medical Apps (MMApps) that may be regulated as medical devices present unique risk management, quality and compliance challenges. Using traditional medical device quality systems and V&V approaches may be too inefficient and cumbersome to support a successful business model and lack of familiarity with global regulatory bodies may lead to unexpected delays or regulatory enforcement actions. SoftwareCPR® is uniquely qualified to support your Mobile App risk management, V&V and compliance activities.
Other emerging areas of focus that we specialize in are compliant use of Agile Methods, development of Safety Assurance Cases, and independent risk based design and code inspections and static analysis.
Training and consulting can be provided in English, Spanish, Chinese, and Italian.
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.