ISO 13485:2016 - Fundamentals -Medical Devices - QMS - Requirements for Regulatory Purposes
About This Course
This instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses.
Key Learning Objectives
At the end of this training, learners will be able to:
- Identify key documents to help you understand ISO 13485:2016
- Recognize the primary elements of ISO 13485:2016
- Identify terms and definitions relative to the application of ISO 13485:2016
- Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
- Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios
Who Should Attend
This course is vital for any medical device professional, including regulatory and quality directors, managers, engineers, and auditors, who is responsible for implementing or working within a quality management system in accordance with ISO 13485:2016. This is a global standard, so it is applicable to devices intended for the market in any jurisdiction around the world.
Tutors
Course tutors selected from the following:
Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.
Alexis Williams - Alexis Williams has worked in a variety of Quality and Regulatory Compliance functions for over 30 years with both world-wide and incubator organizations, supporting QMS development and remediation activities, transformational projects, audit/inspection execution and due diligence activities. She has diverse knowledge across global regulatory jurisdictions and a broad product portfolio specializing in Medical Device, IVD Device, Medical Device Software, combination products and IT solutions and services. Passionate about knowledge sharing, she is dedicated to equipping professionals with the skills needed to navigate complex regulatory landscapes. She is a Certified Medical Device Auditor, (CMDA) and active Member Leader of the American Society for Quality (ASQ) Great Britain Section Committee, currently fulfilling the roles of Voice of the Customer and Secretary.