What is ISO 13485:2016?
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, developers, 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.
This programme will provide participants an insight of the ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes).
- Basic Introduction to ISO 13485: 2016
- Relation ISO 9001:2015 / ISO 13485:2016
- Key issues addressed by ISO 13485:2016
- Integration of Risk Management ISO 14971 in ISO 13485
Who should attend?
- Medical Device Manufacturers.
- Quality Professionals
- Regulatory Professionals
- Internal and external Auditors
- Consultants and anyone involved with the implementation of the standard
Participants are preferred to have basic knowledge in Quality Management system and / or experience in medical device, pharmaceutical operations.
Certificate of participation