ISO 14971:2012

Question 1

what does iso do

Answer 1

provides a process for managing risks associated with medical devices.

Question 2

93/42/EEC

Answer 2

harmonise the laws relating to medical devices within the

Question 3

annex

Answer 3

append or add as an extra or subordinate part, especially to a document. also, an addition to a document

Question 4

ISO 13485

Answer 4

specifies requirements for a quality management system that can be used by
an organization involved in one or more stages of the life-cycle of a medical device, including design and
development, production, storage and distribution, installation, servicing and final decommissioning
and disposal of medical devices, and design and development, or provision of associated activities (e.g.
technical support). The requirements in this International Standard can also be used by suppliers or
other external parties providing product (e.g. raw materials, components, subassemblies, medical
devices, sterilization services, calibration services, distribution services, maintenance services) to such
organizations. The supplier or external party can voluntarily choose to conform to the requirements of
this International Standard or can be required by contract to conform

Question 5

clause

Answer 5

a particular and separate article, stipulation, or proviso in a treaty, bill, or contract.

Question 6

stakeholders

Answer 6

a person with an interest or concern in something, especially a business.