Understanding ISO 13485: Medical Device Quality Management Systems
Location: Distance Learning Course
| Description | Amount |
|---|---|
| 2022 - 2023 On-line Individual | $ 160.00 |
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Medical Device manufacturing businesses provide engineers with multiple opportunities including positions as quality engineers, process engineers, managers or other quality professionals. Even if not directly involved in the quality department, engineers and managers can benefit from understanding the requirements of the International Medical Devices Quality Management Systems Standard, ISO 13485. Understanding 13485:2016 is an overview course that will give the participant a general understanding of the requirements of the standard and provide insights into applying the underlying principles of quality management for medical devices in their business. The participants will also learn how the registration process works to help them in the journey towards an ISO 13485 registered quality system. The 21 CFR 820 FDA regulatory requirements are integrated into this course as they relate to the ISO 13485 requirements. Understanding 13485:2016 is for anyone in engineering, technical, leadership or management positions in the medical device industry. It can be especially beneficial to those who are responsible for quality, quality management, regulatory compliance and/or process improvement. The international quality management system standard, ISO 13485, is the basis for an effective quality system for any business in the medical device industry. This standard is recognized worldwide and provides a ‘road map’ for a quality system that can be tailored to your business. Your medical device quality system should be the way ‘the work gets done’; be easy to maintain; be user friendly; and provide significant internal benefits while facilitating regulatory compliance to both the EU Medical Device Regulation and the 21CFR 820 FDA requirements. The instructor for Understanding ISO 13485:2016, Davis Woodruff, has over three decades of practical experience with clients on 3 continents and in 35 states. He uses a practical approach based on experience, research and education. He provides guidance and assistance to companies implementing and maintaining ISO 13485 quality systems for businesses throughout the U.S. The learning objectives are for participants to:
1. Know What’s Required for Effective Quality Systems
2. Understand the ISO 13485 requirements & required documentation
3. Relate the requirements to your business
4. Overview and compare FDA 21CFR820 Requirements and ISO 13485 as the clauses of the standard are discussed.
5. Know the Benefits of Effective Quality Systems
| Fee: | $160.00 |
|---|---|
| Hours: | 2.00 |
| CEUs: | 0.20 |
Distance Learning Course
Distance Learning CourseDavis Woodruff
Davis M. Woodruff, PE, CMC is an internationally recognized consultant, professional speaker and author. He grew up on a family farm in rural southern Alabama where his family also owned and operated a “country store.” From this background he earned a Chemical Engineering degree from Auburn University, became a Professional Engineer and Certified Management Consultant. He was a manufacturing executive with 3M for ten years and became the youngest manufacturing superintendent in the company prior to forming a management consulting company, Management Methods. Since 1984 he has served clients in 35 states and on 3 continents. From Vermont to Malaysia Davis’ clients include scores of large and small organizations. As a professional speaker, certified management consultant, published author, and professional engineer Davis Woodruff brings immediate benefits to businesses. These benefits include developing leaders; optimizing resource utilization; improving processes, quality and customer satisfaction; and saving time and $$$. Having authored three full-length books, over five dozen articles and multiple online professional development courses, Davis is on the cutting edge of today’s business world. Davis and Lynn have been married since 1970 and they have two daughters, two sons-in-law, three grandchildren and one dog. He is actively involved with his family, in his community and in his church where he leads an adult Bible Study class each week.
