|
| |
|
Resource Center for Medical Device Manufacturers
|
 |
|
| |
| Questions? Please call us at 1-800-425-9843 x2500 or email us at
. |
|
Makers of medical devices face specific concerns in managing their businesses, most significantly, the issue of government regulation. The complexity and costs of FDA regulation vary based on the device category (Class I, II, or III).
Maintaining a highly efficient, low-cost manufacturing environment is also key to success in this industry, since it is labor intensive. Many products are technically advanced, and a sterile and safe facility is often required.