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    Webinar on Test Methods and Standards for Design Verification & Validation

    View: 4502

    Website | Edit Freely

    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 - CFP

    Description :

    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 overview

    Applicable design verification and validation requirements

    Testing requirements including the pertinent ISO Standards

    Translation of user requirements into design inputs

    Role of testing and regulatory requirements

    Focusing on critical to customer and quality requirements

    Design verification and design validation activity cycles

    Traceability and risk management at all stages

    Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)

    Proof for how design outputs meet functional and operational requirements

    Compatibility of the design with components and other accessories

    Test requirements to fulfill acceptance criteria for final products

    How to withstand regulatory scrutiny

    How are changes and their effects controlled and documented during the device life cycle?


    Who Will Benefit:

    Senior management

    Middle management

    Research & Development

    Quality Engineers and Auditors

    Manufacturing Engineers

    Regulatory Affairs Professionals

    Quality Assurance & Quality Control Personnel

    Device Design Team

    Device Development Team

    Device Manufacturing Team

    Verification 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.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.