This introductory course is of value to employees at all levels within the organization of Medical Device manufacturers, and suppliers to the Medical Devices industry including:
One of the unique aspects of medical device manufacture is the specifically designed quality management system, ISO 13485. It extends beyond the standard ISO 9001 in some very specific ways, and therefore requires specialist knowledge and skills. One of the key requirements of running and maintaining an ISO 13485 complaint Quality Management System is having a programme of internal audits.
Many medical device manufacturers internal auditors are only trained to ISO 9001 standards. This course is specifically designed for medical device companies who need internal auditors to work in an ISO 13485 environment. Internal auditing in a regulated environment requires a different approach and also requires cross consideration of regulations not specifically mentioned in ISO 13485 such as Directive 93/42/EEC or other Quality Management Systems such as 21 CFR 820.
This practical and interactive course introduces delegates to auditing ISO 13485 and how it is integrated with the Medical Devices Directive and other regulations.
You will leave the course with the necessary knowledge and skills base needed to be able to plan, conduct, report and follow-up an internal audit. You will also cover the evaluation of corrective and preventive actions arising from the audits.
years of successful work