Quality Puzzle 1

2. U.S. agency responsible for protecting the public health by ensuring the safety, efficacy.
5. Description of what to do, the ideal time required to do it and the best workplace arrangement to do said work.
7. The process of confirming a medical device, program, or software works in its intended use.
9. The international standard for quality management systems for medical devices.

1. A device used to control an irregular heart rhythm.
3. The degree of excellence of something. From a medical device context, it is to ensure that our products are produced to meet or exceed intended use, specifications and requirements.
4. A workplace organization method that uses a list of five Japanese words.
6. Product Lifecycle Management software that is used at Abbott.
8. A systematic, documented process which seeks to obtain evidence and evaluate if products are created in compliance with regulatory requirements and GxP.
10. Premarket submission made to FDA to demonstrate that the device can be marketed as safe and effective.