Across
- 5. Process to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective action to prevent their recurrence.
- 7. A situation where a medical device, process, or material does not meet the requirements
- 9. written, electronic, or oral communication that claims deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device or related to a service that affects the performance of such medical devices
- 10. Process in place to manage the way documents are created, approved, issued, shared, updated, and archived throughout your medical device product lifecycle
Down
- 1. Process that ensure changes to a product or system are introduced in a controlled and coordinated manner
- 2. Name of the eQMS program
- 3. Name of the eQMS platform
- 4. The term that align QMS workstream across different sites
- 6. Process that ensure an organization's is adhering to the standards and regulatory requirements
- 8. Ensure that all activities and systems comply with global quality standards and regulatory requirements to maintain industry leadership and trust.