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This course also features a 30-minute session with our star instructors, Frankie Breedlove who will share insights on the standard and key industry updates.
Course Duration: 2 Days
This two-day training course addresses all of the elements of the 21 CFR 820 changes. The FDA has amended this regulation to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements of ISO 13485:2016. This course aligns regulatory understanding to the framework for the USA with that used by other global regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices to patients
Those who have responsibility for having regulatory knowledge necessary for manufacturing new &/or legacy products into the USA medical device market would benefit from this seminar. This includes: Top Management, Quality/Regulatory managers, Ops managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.
Each participant will receive a seminar manual and a workbook including all team breakout exercises.
Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.
Those who have responsibility for having regulatory knowledge necessary for manufacturing new &/or legacy products into the USA medical device market would benefit from this seminar. This includes: Top Management, Quality/Regulatory managers, Ops managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.
21 CFR 820 - Understanding FDA QMSR Training Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.