This course will deeply explain the certification requirements of medical device industry, so that you can fully grasp the standard requirements of ISO 13485: 2003, and master the relevant requirements of medical device industry and the skills and methods of internal audit of quality system.

Course help

If you want to have a deeper understanding of this course, please refer to >>& gt De Xincheng ISO 13485 internal auditor related information manual.

program objective

In the medical device industry, all medical device manufacturers producing Class II and Class III products must have 2-4 internal auditors, and enterprises without internal auditors should send personnel to participate in the training.

course syllabus

first part

Brief introduction of quality management system in medical device industry

◆ ISO 13485 System Requirements for Medical Devices for Quality System Supervision:

4 Quality management system 5 Management responsibilities 6 Resource management 7 Product realization 8 Measurement, analysis and improvement

◆ ISO 13485 system document requirements and process control: risk analysis/assessment.

the second part

◆ Legal requirements of medical devices

European medical device directive MDD, active implantable medical device directive AIMD, in vitro diagnostic medical device directive IVDD, China GMP, etc.

◆ISO 65438 Internal Audit Planning +03485

◆ Internal audit skills

◆ Third-party quality system certification process and common problems in certification.

◆ Examination