SoftwareCPR^®

SoftwareCPR^® Partners have played key roles in development of FDA recognized standards for Medical Device Software and Risk Management, 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 and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management and technical files, as well as validation services for Pharmaceutical companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.

Training and consulting can be provided in English, Chinese, Italian, and Spanish

FDA's New Medical Device Data Systems classification rule 21 CFR Part 880 requires quality systems compliance for a wide range of software. We can help those new to FDA regulation achieve compliance in an efficient manner. We have been actively involved in development of the new AAMI/FDA Guidance for MDDS Quality Systems.

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.