Training Overview
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.”
Training Benefits
- Knowledge of Medical Devices Quality Management System & it’s requirements in the organization
- Understand Medical Device Family
- Understand how to prepare Medical Device File
- Risk Management
- Role of Leadership in implementing Medical Devices Quality Management System
- Knowledge about Internal Audit, MRM, Continual Improvement
- Monitoring and Measurement of Processes and Product
- Understand Medical Device Identification and Traceability
Training Methodology
- Presentation
- Interactive Session
- Q&A Session
Training Content
- Introduction to ISO 13485:2016
- ISO 13485:2016 Clauses and Requirements
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis and Improvement
Who Should Attend
- Personnel responsible for the implementation of Quality Management System in the organization
- Cross Functional Teams from the organization
- Students or any personnel who wants to understand ISO 13485 standard