Processes for developing software for use in medical devices or for regulated health IT applications like 'Mobile Medical Device Applications' or 'Medical Device Data Systems" are often perceived as 'not compatible with current agile software development methodologies. This is often because an agile manifesto core value of: "Working software over comprehensive documentation" seems to conflict with old school 'waterfall' process definitions that seem to form the basis of many regulations.
This webinar will provide introductory information dispelling that myth and provide some case study information to help your teams remain 'agile' but able to pass regulatory scrutiny where required.
Principal Consultant @ MedSoft Consulting
Rob Hyatt has a long record of accomplishments in the Medical Device and Pharmaceutical fields. He has over 35 years of experience in developing and validating various products in highly regulated environments and the Health IT sector. Mr. Hyatt has held senior consultant positions in medical device startups, Fortune 500 companies, and Healthcare provider organizations. He has severed on various industry committees helping standardize and define software processes to help streamline regulatory requirements. Specialties: FDA Regulatory Affairs, Medical Device Verification, and Validation, Project/Product Management, Software Development, Safety Engineering Activities.