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Certifications & Registrations

Optimized design. Maximum quality and value.

Norman Noble optimizes a design to ensure manufacturability from prototype through commercialization.

Providing the Manufacturing Foresight Now for Benefits Later

Facts at a Glance:

We believe control and inspection are essential to assuring accuracy in medical device manufacturing, which requires an unwavering commitment to quality. Our quality system is registered to IS0 13485:2003 & EN ISO 13485:2012 and our Process Validation Department works to meet your manufacturing objectives and provide IQ/OQ, MSV, PQ/PPQ, TMV, DOE, and risk analysis, etc., to fulfill your product and regulatory requirements.

Norman Noble has performed more than 1,700 process validations for Class II and III medical implants and devices. Having experience with 18 of the top medical device OEMs, we’ve distilled our validation process into a fine-tuned, but continually progressing set of best practices.

Norman Noble maintains FDA establishment registration (Title 21 CFR Part 807) for all applicable finished medical devices produced. Our Quality Group also actively supports customers in achieving approval in foreign markets such as Japan’s PMDA Medical Device Registration or Korea’s Ministry of Food and Drug Safety (MFDS) approval.

To support our range of customers and industries served Norman Noble also maintains ITAR (International Trafficking in Arms) registration through the Department of State Directorate of Defense Trade Controls. Compliance with EAR (Export Administration Regulations), enforced by the Commerce Department’s Bureau of Industry and Security is also maintained.

Environmental Policy – Norman Noble is committed to environmental responsibility and maintains a management system that strives to achieve continual quality improvement and pollution prevention in all aspects of our business.