0080-qms-implementation-training-program-based-on-iso-13485-2016-standard
Implementation Training Program on Medical Devices - Quality Management System based on ISO 13485:2016
Face-to-face Training2 DaysIntermediate
- Understand the quality management system requirements for medical device industries
- Understand the Implementation of ISO 13485:2016 based Quality management system
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Develop safe and effective medical devices
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- Quality concepts
- Overview of quality management system
- Benefits and purpose of quality management system
- Key definitions
- ISO 13485:2016 standard requirements
- Implementation of Process approach
- Setting quality policy and objectives
- Implementing risk based approach
- Overview of risk management
- Identification of requirements of documentation and records
- Preferred to have basic knowledge of Quality ManagementSystem and / or experience in medical device operations.
- Understand the quality concepts
- Get an overview of quality management system
- Understand the benefits and purpose of quality management system
- Review the ISO 13485:2016 standard requirements
- Learn how to develop safe and effective medical devices
- At the end of the course, participants will receive anattendance certificate from TÜV SÜD South Asia.
- Understand the quality concepts
- Get an overview of quality management system
- Understand the benefits and purpose of quality management system
- Review the ISO 13485:2016 standard requirements
- Learn how to develop safe and effective medical devices
What will you learn?
The success of an organisation, the reach of its products and services in the market, efficient internal procedures, and a healthy economic status all hinge on how we consistently ensure, maintain, and improve MD-QMS requirements and regulatory compliance. Your understanding and implementation of these requirements play a significant role in this process, underscoring your responsibility and commitment. ISO 13485 – Medical Device – Quality Management Systems – Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.
Course outline
Day – 1
Day – 2
Note:
Classroom exercises will be spread over two days of the training
Pre-requisites
Learning & Career benefits
Examination & Certification
FAQ
1. When can I get the certificate?
ISO 13485:2016 Quality Management System Implementation Training certification will be issued within 21 working days from the examination date.
2. When can I get the training material and invite?
One day before the commencement of the training program.
3. How do I pay the fees for training and examination?
Online mode
4. What are the benefits of the ISO 13485:2016 Quality Management System Implementation Training Program?
Please refer to Cancellation and Refund policy page.