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- Establishment of a quality management system for medical devices. A manufacturer must have quality procedures that are documented, controlled, and effectively implemented and maintained.
- Ensuring that personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.
- A detailed plan on how remedial processes will be used to assure conformity.
- Planning and performance of regular internal audits.
- Creating a procedure to gather feedback from customers and a feedback system to monitor emerging problems.
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