Steps for manufacturing successful product

According to the FD&C Act, it is required that domestic or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. More details can be obtained from
◦ The Quality System Regulations – 21CFR 820(QSR’s)and
◦ ISO Standard 13485:2003.

The QS consists of four major actions: Design -> Manufacture -> Distribute -> Monitor performance. The FDA's QSR manual shows how any new entrepreneur can start a successful medical device company by sequentially following the steps below.

1. Obtaining information on GMP requirements;
2. Determining the appropriate quality system needed to control the design, production and distribution of the proposed device;
3. Designing products and processes;
4. Training employees;
5. Acquiring adequate facilities;
6. Purchasing and installing processing equipment;
7. Drafting the device master record;
8. Noting how to change the device master records;
9. Procuring components and materials;
10. Producing devices;
11. Labeling devices;
12. Evaluating finished devices;
13. Packaging devices;
14. Distributing devices;
15. Processing complaints and analyzing service and repair data;
16. Servicing devices;
17. Auditing and correcting deficiencies in the quality system; and,
18. Preparing for an FDA inspection.

It is to be noted how each of the steps is a comprehensive process in itself. These steps if followed according to the FDA protocols will ensure production of a successful medical device.