Reducing risks and recalls : Safety assurance cases for medical devices

CDRH 'Puzzled' by Class 1 Recalls Jump, (2013)

Heneghan C., Thompson M., Billingsley M., Et al., Medical-device recalls in the UK and the device-regulation process: Retrospective review of safety notices and alerts, BMJ Open, 1, 1, (2011)

GessNet TurboAC Risk Management and Assurance Case Software White Paper, (2013)

Health IT and Patient Safety: Building Safer Systems for Better Care, (2012)

Medical Devices-Application of Risk Management to Medical Devices, (2007)

Weinstock C., Goodenough J., Towards An Assurance Case Practice for Medical Devices, (2009)

Ray A., Assurance Cases: Their Use Today and the Challenges Ahead, 46, 3, pp. 195-200, (2012)

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, (2011)

Guidance for Industry and FDA Staff: Total Product Life Cycle: Infusion Pump: Premarket Notification [510(k)] Submissions, (2013)

CDRH 'Puzzled' by Class 1 Recalls Jump, (2013)

Heneghan C., Thompson M., Billingsley M., Et al., Medical-device recalls in the UK and the device-regulation process: Retrospective review of safety notices and alerts, BMJ Open, 1, 1, (2011)

GessNet TurboAC Risk Management and Assurance Case Software White Paper, (2013)

Health IT and Patient Safety: Building Safer Systems for Better Care, (2012)

Medical Devices-Application of Risk Management to Medical Devices, (2007)

Weinstock C., Goodenough J., Towards An Assurance Case Practice for Medical Devices, (2009)

Ray A., Assurance Cases: Their Use Today and the Challenges Ahead, 46, 3, pp. 195-200, (2012)

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, (2011)

Guidance for Industry and FDA Staff: Total Product Life Cycle: Infusion Pump: Premarket Notification [510(k)] Submissions, (2013)