The key elements can be described as follows:
Clinical Evaluation
Assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer
Labeling
Label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents
Medical Device Family
Group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function.
Sterile Barrier System
Minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use.
Sterile Medical Device
Medical device intended to meet the requirements for sterility
Medical Device File
For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.
Work Environment
The organization shall document the requirements for the work environment needed to achieve conformity to product requirements.
If the conditions for the work environment can have an adverse effect on product quality, the organization shall document the requirements for the work environment and the procedures to monitor & control the work environment.
Contamination Control
As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel or product.
For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes.
Planning of Product Realization
Plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system.
Design & Development
Plan and control the design and development of product. As appropriate, design and development planning documents shall be maintained and updated as the design and development progresses.
Cleanliness of Product
Document requirements for cleanliness of product or contamination control of product if:
a) Product is cleaned by the organization prior to sterilization or its use;
b) Product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or its use;
c) Product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;
d) product is supplied to be used non-sterile, and its cleanliness is of significance in use;
e) Process agents are to be removed from product during manufacture
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