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Group MD200 - DESIGN AND DOCUMENT CONTROLS
Medical Device Group -
Consists of MD20, MD21, MD22 and MD23 |
| $375.00 |
Qty. |
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MD20 - DESIGN CONTROLS
To describe the requirements for the
design control system which ensures that devices are designed
to meet user needs, intended uses, and specified requirements. |
| $189.00 |
Qty. |
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MD21 - DEVICE MASTER RECORD
To describe the organization,
content, creation and use of the Device Master Record (DMR)
employed in the production of all medical devices distributed
by the Company. |
| $189.00 |
Qty. |
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MD22 - DOCUMENT AND CHANGE CONTROLS
To describe the
process, procedures and requirements for controlling documents
and changes to assure that documents and changes
are adequately evaluated, reviewed, and approved prior to
implementation. |
| $189.00 |
Qty. |
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MD23 - RISK MANAGEMENT
To describe the systematic
management of the risks associated with the use of medical
devices throughout the product life cycle from design to
post-production. Risk management activities include analysis, evaluation, control, and post-production review activities. Risk management activities are also key elements of the Quality Management System. |
| $189.00 |
Qty. |
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