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Norman Noble logo

Certifications & Regulations

Optimized Design. Maximum Quality and Value.

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

Norman Noble ISO 13485:2018 registered

PROVIDING THE MANUFACTURING FORESIGHT NOW FOR BENEFITS LATER

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 13485:2016 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.

Click here to download a PDF of Norman Noble's ISO 13485:2016 Certificate.

PROVIDING THE MANUFACTURING FORESIGHT NOW FOR BENEFITS LATER

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 13485:2016 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.

Click here to download a PDF of Norman Noble's ISO 13485:2016 Certificate.

FACTS AT A GLANCE

FDA & FOREIGN REGULATIONS

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

EAR

  • Norman Noble maintains compliance with EAR (Export Administration Regulations), enforced by the Commerce Department’s Bureau of Industry and Security.

ENVIRONMENTAL POLICY

  • Norman Noble is committed to environmental responsibility.
  • We maintain a management system that strives to achieve continual quality improvement and pollution prevention in all aspects of our business.