| |
|
| |
 |
Group MD100 - MANAGEMENT CONTROLS
Medical Device Group - Consists of MD10, MD11, MD12 and MD13 |
| $375.00 |
Qty. |
|
| |
|
MD10 - MANAGEMENT RESPONSIBILITY
To describe the responsibilities for establishing, implementing
and maintaining the Quality Management System,
reviewing the suitability and effectiveness of this system, and
providing resources to implement this system, maintain its effectiveness,
and meet regulatory and customer requirements.
Also to describe management's responsibility for Risk Management
and customer requirement related activities. |
| $189.00 |
Qty. |
|
| |
|
MD11 - INTERNAL QUALITY AUDIT
To describe the process and instructions
for performing internal audits to assess the Quality Management System performance, assure it is in compliance with established requirements, and is operating effectively. |
| $189.00 |
Qty. |
|
| |
|
MD12 - REGULATORY AGENCY INSPECTION
To describe the process for managing visits or inspections by regulatory agencies having legal authority over medical devices manufactured or distributed by the Company. |
| $189.00 |
Qty. |
|
| |
|
MD13 - PERSONNEL TRAINING PROGRAM
To describe a system
that assures that all personnel are adequately trained to properly
perform their assigned responsibilities. |
| $189.00 |
Qty. |
|
| |
|
|
