Quality & Regulatory
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Registered as a U.S. Food and Drug Administration Medical Device Establishment since 1978 (1825560), CFI Medical complies with 21 CFR 820 Quality System Requirements and maintains an extensive FDA product listing and 510K premarket notifications.
CFI’s ISO 13485: 2003 Medical Devices – Quality Management System Certification (#FM524030) and Medical Devices Directive certification (#CE 72113) provides for CE marking and access to the European market. Access to Canada is achieved through Health Canada Medical Device Establishment License #1499 and Medical Device Class II licenses #85588 and #85589. Some CFI Medical devices may not be licensed for distribution per Canadian law. Please contact CFI Medical Customer Service for information on specific product availability. CFI Medical Solutions strives for compliance with regulatory bodies on every continent. Based on these credentials, CFI can assist you in achieving regulatory compliance, offer private labeling options, and provide contract manufacturing services. CFI’s specialized engineering capabilities and full design controls can develop products for you or with you. For additional CFI regulatory information, contact John Schaefer at or at 810-750-5300, ext. 232. |
Quality PolicyIt is the policy of CFI Medical to satisfy our customers’ expectations for quality, delivery, and service while conforming to applicable regulatory requirements and continually improving the effectiveness of the quality management system. |
Certificates
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| ISO 13485 #FM 524030 | CE Mark #CE 72113 | Health Canada Registered Medical Device Establishment #1499 |