Introduction Training course - ISO 13485:2016
About the Course
This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.
you will learn
the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
Identify the relationship between ISO 13485:2016 and European Medical Device Directives
Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
Your Instructor
Siddharth Kumar
Mr. S. Kumar has the vast experiance of Drugs and Cosmetics act, Medical Rule -2017, EU Regulation 2017/745, EU Regulation 2017/746, ISO 13485:2016, ISO 14971: 2019 and other ISO Standards. he worked for the pharmaceuticals as well as medical device industries for 20 years.
Price
INR 5000.00
Duration
2 Days