What is Medical Device Compliance?

Medical Device Compliance Definition

Medical device compliance requires manufacturers to adhere to all applicable laws, regulations, and standards for their target markets. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Commission, and International Organization for Standardization (ISO) enforce several regulations and standards to ensure that medical device manufacturers develop safe and effective products that perform as intended. To demonstrate compliance, manufacturers must meet the requirements set forth by these agencies such as implementing a quality management system, establishing proper design controls, conducting post-market surveillance, and collecting clinical evidence.

Source: https://blog.arrowfast.tech

The Cost

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

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