ISO 13485:2016 Lead Auditor Training – Medical Devices Quality Management
The global medical device market is worth over $450 billion annually, making safety and compliance critical. ISO 13485:2016 sets out requirements for a QMS specific to medical devices. This Lead Auditor course prepares professionals to audit organizations in the medical device supply chain, ensuring product safety, regulatory compliance, and patient well-being.
Learning Objectives
By the end of this course, participants will be able to:
- Interpret ISO 13485 requirements in medical device manufacturing and supply.
- Plan, conduct, and report audits per ISO 19011 and ISO/IEC 17021-1.
- Evaluate risk management, sterilization, and traceability processes.
- Lead audit teams in highly regulated environments.
- Provide audit results that enhance compliance with global health regulations.
Who Should Attend
This course is designed for:
- Quality and Regulatory Affairs Managers in medical device companies
- Internal Auditors and Consultants in the healthcare sector
- Professionals involved in device design, manufacturing, and distribution
- Auditors seeking specialization in medical devices
Course Content
5 Days
Benefits of the Course
- Improve patient safety and product reliability.
- Gain recognition as a certified Medical Devices Lead Auditor.
- Support compliance with regulatory requirements such as FDA and EU MDR