Course description
Quality Management Systems for Medical Devices Based on ISO 13485
Being certified against ISO 13485 will enable you to improve, monitor, and maintain effective processes, in order to ensure the achievement of planned results based on the customer, quality and regulatory requirements. This certificate will prove that you have the necessary expertise to establish a Quality Management System for the design, development, production, and manufacturing of medical devices, while ensuring that the organization is constantly delivering safe medical devices.
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Upcoming start dates
Who should attend?
Attendees that want to build strong rapport and trust with teammates through team building (NASBA Field of Study: Production: Non-Technical
Certification / Credits
Objectives
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
- Learn how to interpret the ISO 13485 requirements in the specific context of an organization
- Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
- Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
- Understand the operations of a Medical Devices Quality Management System based on ISO 13485
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
- Learn how to lead an audit and audit team
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
- Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
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GoldSRD
GoldSRD is a leading provider of high-quality, interactive professional development. We have over 200 full-day courses on technical capabilities (Internal Audit, Accounting, Finance, IT Audit and Microsoft-Office specific courses) and People-Centric (“soft”) skills. Our Founder, Danny M. Goldberg, is a...