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


What are the regulatory requirements for medical devices?

The regulations that apply will depend on where you plan to market and sell your medical device. For example, if you plan to market and sell your product in the United States, then the FDA is the main governing body. If you plan to market and sell your product in Europe, you will need to comply with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR).

What are the most common compliance issues cited by the FDA?

The most common compliance issues cited by the FDA are:

  • Design Controls
  • Corrective and Preventive Actions (CAPAs)
  • Complaints
  • Medical Device Reporting

*Source: https://www.meddeviceonline.com

Is FDA approval required for medical devices?

Before a medical device can be lawfully sold in the United States, the individual or company that wishes to sell it must first obtain FDA approval. They must show that the product is reasonably safe and effective for a specific use to gain clearance.

*Source: https://www.fda.gov

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.