Fundamentals of ISO 13485:2016 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes
June 14 – 15, 2022
This training course is 16 hours. Students will understand the requirements of ISO 13485:2016 and understand the design specifications for the 2016 version of ISO 13485, the difference between ISO13485:2003 and ISO 13485:2016. This course will prepare you to comprehend the intent and meaning of all clauses of ISO 13485:2016 and to recognize the interrelationship and linkages between the clauses and requirements.
Who Should Attend
This course is vital for any medical device professional to include regulatory and quality directors, managers, engineers and auditors responsible for implementing or working within a quality management system in accordance with ISO 13485:2016. This is global standard so it is applicable to devices intended for market in any jurisdiction around the world.