What you’ll learn
- Learn all ISO 13485 characteristics including the specific procedures, documentations, regulatory requirements and risk management
- The role of ISO 13485 2016 in the United States and EU regulation system.
- Learn the Active Implantable Medical Device Directive 90/385/EEC.
- Understand realization of a medical device, with reference to various types of processes and products in the industry
- ISO 9000:2000: Quality management systems
- Supply chain management and activities of medical devices
- Identifying and Implementing the Quality Management System for medical devices
- Planning quality objectives of product realization
- Learn Quality policy, Quality objectives, Realization process, Requirements and Effectiveness for medical device manufactoring
- Master planning of the realization of the medical device and building a Quality Plan
- Validation and Verification Activities
- Evaluation criteria of design and development of medical devices
- Building device history record (DHR) and device master record (DMR)
- Control of production service and service provision
How to Enroll ISO 13485: Medical Devices QMS Certification Masterclass course?
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ISO 13485: Medical Devices QMS Certification Masterclass Course coupon is limited to the first 1,000 enrollments. Click 'Enroll Now' to secure your spot and dive into this course on Udemy before it reaches its enrollment limits!
