Medical Device Software - Regulation and Standards
September 10, 2015 - Birmingham UKAscensys Medical Limited
peter.brady@ascensysmedical.com
Phone:+447984648628
Rejection of regulatory submissions for the approval for sale of a medical device causes delayed product launch, lost revenues, increased costs and damaged reputation. For devices containing software we can help minimise the risk of rejected submissions through our training solutions which detail best practice software development for medical devices. Frequently asked questions often relate to the amount of detail required in, for example, software requirements specifications, detailed design documents and hazard analyses tables - our cost-effective training programmes help you get the balance right and achieve better compliance and faster time to market. 50% reduction in cost for eligible SMEs - please contact the organiser for details. What you will learn: Software Development •Development Planning •Requirements Analysis •Architectural Design •Detailed Design •Coding and Verification •Integration and Integration Testing •Software System Testing •Software Release Software Maintenance •Maintenance Planning •Problem and Modification Analysis •Modification Implementation •Risk Management of Software Changes •Change Control •Configuration Management Risk Management •Safety Risk Classification •Risk Management Planning •Risk Identification •Risk Analysis •Risk Evaluation •Risk Control •Residual Risk Analysis •Risk Benefit Analysis Who should attend Medical Device Manufacturers: R&D Managers, Software Managers, Project Managers, Software Architects and Engineers.