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Group MD300 - CORRECTIVE AND PREVENTIVE ACTION
Medical Device Group - Consists of MD30, MD31, MD32, MD33, MD34 and MD35 |
| $555.00 |
Qty. |
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MD30 - CORRECTIVE AND PREVENTIVE ACTION
To describe
the systematic approach for establishing a corrective and
preventive action (CAPA) system to capture non conformances,
their related quality investigations and trends to
prevent recurrence. This procedure discusses the communication
and documentation activities associated with
the CAPA system. |
| $189.00 |
Qty. |
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MD31 - SERVICING
To describe instructions for performing servicing
of finished, distributed medical devices and verifying that
the serviced devices meet specified requirements. |
| $189.00 |
Qty. |
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MD32 - PRODUCT RECALLS
To describe the requirements and process
for determining whether a product recall, field correction,
or removal is reportable to FDA and to define the
reporting requirements for such actions. |
| $189.00 |
Qty. |
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MD33 - MEDICAL DEVICE REPORTING
To describe the procedure
for the mandatory reporting of adverse events and
product problems to the FDA in accordance with the FDA's
Medical Device Reporting Requirements. |
| $189.00 |
Qty. |
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MD34 - COMPLAINT HANDLING
To describe the process for receiving,
reviewing and evaluating complaints, and describe the
responsibilities associated with the complaint handling process.
This procedure also describes some elements of the customer
communication and feedback process. |
| $189.00 |
Qty. |
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MD35 - QUALITY INVESTIGATIONS
To describe the procedures
for conducting and documenting investigations of
non conformances which are a failure to meet predetermined
material, product, process, facilities, equipment or
system requirements or observations or trends that could
potentially affect product quality. |
| $189.00 |
Qty. |
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