ISO 13485:2016 Requirement
Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.
This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with with ISO 9001:2015, the European Medical Device Directive and the US FDA's Quality System Regulation. The relationship with ISO 14971, Application of Risk Management to Medical Devices is also explored during the course.
How will I benefit?
This course will help you:
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants
- Anyone involved with the implementation of the standard
What will I learn?
On completion of this training, participants will be able to:
- Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Understand the relationship between ISO 13485:2016 and European Medical Device Directives
- Use ISO 13485:2016 as the basis of regulatory requirements worldwide.
What's included?
- ราคานี้รวมค่าเอกสารประกอบการฝึกอบรม
- ราคายังไม่รวม Vat 7% สามารถหัก ณ ที่จ่ายได้
- ผู้เข้าอบรมจะได้รับใบรับรองของ BSI Training Academy หลังเสร็จสิ้นการฝึกอบรม
รับโค้ดส่วนลด DIS250
ราคา 5,000 บาท จากปกติ 5,250 บาท (ยังไม่รวม Vat)
*โปรดกรอกรหัส DIS250 ที่หน้าสมัครออนไลน์ในช่องหมายเลขคูปอง
