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Resource Center for Medical Device Manufacturers

Managing Compliance with 21 CFR Part 11
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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.