Design Verification, Validation and Testing for Medical Devices
November 16, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4458
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfill its mandate for safety and efficacy of all medical devices. The design controls are now being expected from outside equipment manufacturers (OEM) and all suppliers to the medical device industry. This webinar will educate you on the key areas that you need to focus on to fulfill the design control and testing requirements for your medical device at various phases of your product development.