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2019 Course: Robust Management of Design & Development for Medical Devices as per ISO 13485:2016

Dublin, Jan. 20, 2020 (GLOBE NEWSWIRE) -- The "Robust Management of Design and Development for Medical Devices as per ISO 13485:2016" webinar has been added to ResearchAndMarkets.com's offering.

The course offers explanation and illustrative high-quality presentations on difficult concepts of medical devices' design control as per ISO 13485:2016 and best industrial practices.

ISO 13485:2016 is the current international standard for the QMS (quality management system) of medical devices' manufacturers and suppliers. The standard title is also extended with a supplementary expression: "For Regulatory Purposes". It reflects the standard is also designed in a way to help companies in meeting the homogenous regulatory requirements as well.

Design and development in a QMS (quality management system) is the most difficult part for any industry. In the same way; medical devices sector are no exception and due to increased regulatory concern in this industry; design and development in medical device is even more complex process which encompasses different phases and roles. Hence this course simplifies the process of design control for medical devices.

The course presents an exclusive model based on ISO 13485:2016 requirements on design control compared with popular FDA waterfall model. The model is known as the Rising model and is designed by the Speaker and Presenter of this Webinar Course and is unique way of explaining the ISO 13485 requirements on design and development.

Who Should Attend?

This webinar will provide valuable assistance to all companies working with design and development of medical devices and are looking for conformance of ISO 13485:2016 certification or compliance with FDA Design Control Requirements.

The employees who will benefit include:

  • Executive management
  • Research and Development management
  • Regulatory management
  • Regulatory affairs and Quality Assurance professionals
  • Consultants
  • Senior and mid-level management
  • Quality system auditors

Key Topics Covered

1. ISO 13485:2016 Standard Introduction

2. Discussion on FDA Waterfall Model and Rising Model

3. Coverage of followings requirements of design and development:

  • Planning
  • Procedure
  • Inputs
  • Outputs
  • Review
  • Verification
  • Validation
  • Transfer
  • Changes
  • File

4. Summary of ISO 13485 Requirements on Medical Devices' Design

Companies Mentioned

  • DePuy
  • J & J
  • Carefusion
  • Teleflex
  • KLS Martin

For more information about this webinar visit https://www.researchandmarkets.com/r/s2ssu

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