Webinar on Test Methods and Standards for Design Verification & Validation
Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1694 |
Category Medical Devices
Deadline: July 29, 2106 | Date: July 29, 2106
Venue/Country: Online, Canada
Updated: 2016-06-30 18:50:56 (GMT+9)
Call For Papers - CFPDescription : 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.Areas Covered in the Session :Product development process overviewApplicable design verification and validation requirementsTesting requirements including the pertinent ISO StandardsTranslation of user requirements into design inputsRole of testing and regulatory requirementsFocusing on critical to customer and quality requirementsDesign verification and design validation activity cyclesTraceability and risk management at all stagesDesign outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)Proof for how design outputs meet functional and operational requirementsCompatibility of the design with components and other accessoriesTest requirements to fulfill acceptance criteria for final productsHow to withstand regulatory scrutinyHow are changes and their effects controlled and documented during the device life cycle?SummaryWho Will Benefit:Senior managementMiddle managementResearch & DevelopmentQuality Engineers and AuditorsManufacturing EngineersRegulatory Affairs ProfessionalsQuality Assurance & Quality Control PersonnelDevice Design TeamDevice Development TeamDevice Manufacturing TeamVerification and/or Validation planning, execution and documentation for devices.Startup Company Leaders
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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