Medical Device Regulations

Medical devices are subject to strict regulations to ensure safety and efficacy. Understanding these regulations is essential for manufacturers and healthcare providers alike.

Key Regulatory Bodies

• FDA: The Food and Drug Administration oversees the approval of medical devices.
• ISO: International Organization for Standardization sets global standards.
• CE Marking: Indicates compliance with European health, safety, and environmental protection standards.

Staying informed about regulations can help ensure that medical devices are safe for patient use and meet necessary standards.