ISO 13485:2016 Clause-by-Clause Medical Device Quality Management System Auditing, Case Studies & Exam Preparation
Sub Category
- Career Development
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Objectives
- Interpret ISO 13485:2016 requirements clause by clause
- Understand medical device QMS requirements across the full lifecycle
- Apply risk-based auditing techniques specific to ISO 13485
- Plan and conduct Stage 1 and Stage 2 certification audits
- Audit design controls, production processes, validation, and suppliers
- Evaluate documentation, records, and regulatory evidence
- Identify and classify major and minor nonconformities
- Write clear, objective, and compliant audit findings
- Lead audit teams and manage audit programs professionally
- Prepare confidently for ISO 13485 Lead Auditor certification exams
Pre Requisites
- Basic understanding of quality management systems (QMS) concepts
- Familiarity with the medical device industry or regulated environments
- Interest in auditing, compliance, or regulatory standards
- Professionals new to ISO 13485 auditing, and Experienced quality or regulatory professionals seeking Lead Auditor certification.
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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