Definition

1- medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose.

2- sterile medical device category of medical device intended to meet the requirements for sterility.

3- customer complaint written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market

4- complainant person, organization or its representative, making a complaint

5- customer organization or person that receives a product

6- feedback opinions, comments and expressions of interest in the products or the complaints-handling process

7- process set of interrelated or interacting activities which transforms inputs into outputs

8- measurement process set of operations to determine the value of a quantity

9- measurement management system set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control of measurement processes

10- quality management system realization process of establishing, documenting, implementing, maintaining and continually improving a quality management system .

11- quality management system consultant person who assists the organization on quality management system realization, giving advice or information

12- work instructions detailed descriptions of how to perform and record tasks.

13- form document used to record data required by the quality management system

14- Quality The degree to which a set of inherent characterstics fulfils requirements.

15- manufacturer natural or legal person, individual or organization with the responsibility for packaging and/or sterilizing the medical device.

16- product combination of both the medical device and/or additional components with the final package

17- qualification documented evidence that all specified design and performance requirements are met

18- sterile free from viable microorganisms

19- validation documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.

20 - Ethylene Oxide A colorless gas with a characteristic ether-like odor that is used by various facets of the health care industry for the sterilization of delicate instruments and heat or moisture sensitive devices.