MEDICAL DEVICE QUALITY SYSTEMS MANUAL...

530 pages of compliance quality initiatives for all companies operating under US GMP requirements...

...covers the Quality System regulation and the basic Good Manufacturing Practices (GMP) requirements that all manufacturers and distributors must consider when they plan to manufacture medical devices, including medical device kits, trays or packs, for distribution in the United States. Model procedures and sample forms are also included in the manual to assist manufacturers.

Adherence to the medical device Quality System regulation makes good business sense and also serves public health aims -- two very good reasons for the Food and Drug Administration (FDA) to encourage compliance. However, a prerequisite to complying with a regulation is a clear understanding of its content.

Covers:  (read more)

1. The Quality System Regulation

2. Quality Systems

3. Design Controls

4. Process Validation

5. Personnel

6. Buildings and Environment

7. Equipment and Calibration

8. Device Master Record

9. Document and Change Control

10. Purchasing and Acceptance Activities

11. Labeling

12. Product Evaluation

13. Packaging

14. Storage Distribution and Installation

15. Complaints

16. Servicing

17. Quality Systems Audits

18. Factory Inspections