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ISO 13485 2016 Quality management systems - Requirements for regulatory purposes - By AtoZ Compliance
Key Take Away:
Learn how Medical device designers and manufacturers can follow ISO 13485 2016 to maintain their Quality Management System training (QMS) processes in a state of control, via controlled documents and objective evidence in the form of record keeping requirements.
All life science businesses are required to maintain their Quality Management System training (QMS) processes in a state of control, via controlled documents and objective evidence in the form of record keeping requirements.
Medical device designers and manufacturers are required to follow ISO 13485 training, and will be expected to implement the 2016 revision changes.
Why Should You Attend:
The changes to this standard will have profound implications to how Quality Management Systems (QMSs) interact internally and between different supply chain agents.
It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.
Areas Covered In This Webinar:
ISO 13485 2016 versus ISO 13485 2003
Overview of ISO 13485 2016:
Changes to ISO 13485 2016, although allowing more flexibility, introduces significant, comprehensive, and systemic changes involving the following areas:
Medical device file
Design and development
Process validation guidance
Delivery of nonconforming product improvement
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
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