ISO 13485:2016 Medical devices.
ISO 13485:2016 states the requirements for a Quality Management System (QMS), in which organizations will demonstrate their ability to provide devices needed in the medical industry and related services that need to comply with regulatory requirements and customer needs.
This standard can also be used by external parties and suppliers who supply such products and services to those organizations.
How ISO 13485:2016 Benefits your business !
- ISO 13485 Development: Understanding the company processes.
- Prepare Gap Analysis and Documentation.
- Develop procedures according to the ISO 13485 requirements.
- Training: Train key personnel for awareness training courses and internal audit training courses.
- Implementation: Assist the team in the implementation of the procedures.
- Internal Audit: Conduct an internal audit to ensure compliance with the requirement.
- Recommend further improvements.