Process Validation

Process validation begins at Norman Noble, Inc. with a clear understanding of our customers' needs coupled with ISO standards, current Good Manufacturing Practices and the NNI Quality Policy.

 

During the review process of purchase orders and contracts, our Process Validation Department works with our customers and the NNI management team to develop a validation strategy and a Risk Analysis that incorporates qualified machinery and trained personnel using the most repeatable and reliable test methods.  Process development continues with the manufacturing of “pre-qualification” product.

 

Our engineering staff may develop multiple Designs of Experiments to further define the ranges of settings for variable process parameters. The process will then be qualified by running product at the extremes of these variables, indicating that all products manufactured within the boundaries of these variables produces predictable results. Multiple lots of product are then manufactured and documented at the nominal settings of these parameters over time to challenge various operating conditions, which completes the process validation activities. Additional Product/Process Performance Qualification activities may be performed at the request of the customer.

All validation activities are well documented in our internal Device Master Records, with a statistical approach towards certification of product meeting or exceeding our customer’s requirements.

FDA Compliant Validation of Medtech Implants and Devices - A white paper illustrating Process Validation, IQ, OQ, PQ and FDA Regulations.

Glossary of Validation Acronyms

Presentation on Validation for next generation implants.

 


Automated 100% Dimensional
Inspection of Vascular Stent

 

Capabilities:

  • Automated Fine Scan systems for 100% dimensional inspection & touch probe capability for measuring wall thickness with both flat & rotary capabilities.
  • Profile software that detects missing features & slugs.
  • Our newest Sierra FineScan system offers faster visual OD inspection & wall thickness touch probe capabilities, and can inspect stents greater than 200mm in length.
  • SmartScope Quest 650 Multi Sensor Measuring System- with Grid Projector and Touch Probe capabilities.
  • Micro Vu Vector systems provide manual dimensional inspection of contoured parts.
  • SEM for metallurgical analysis.
  • Quality System is registered to ISO 13485:2003 & EN ISO 13485:2012 & ISO 9001:2008 and per FDA QSR 21 CFR Part 820.
  • FDA audited facilities.
  • Process Validation Department - Fully trained staff develops validation strategies with customers and performs IQ/OQ, PQ/PPQ, MSV, TMV, DOE, and risk analysis.
  • Japan FMA accredited (certificate for foreign medical device manufacturers from Japan’s Pharmaceuticals & Medical Device Agency for non-sterile medical devices).
  • ITAR registered.
  • 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.

 

 

Quality Department

Microprecision machining for the medtech industry demands exceptional inspection, measurement and assembly capabilities. As an ISO 9001:2008 and ISO 13485:2003 & EN ISO 13485:2012 certified company, we make quality inspection an integral part of the production process. Our investment in quality is evident in ouradvanced inspection and measurement equipment. Customers know that our registration to ISO 13485:2003 & EN ISO 13485:2012 reflects our own internal quality control inspection system. We pay strict attention to the details of our work – from planning, managing and administering the job to machining and finishing accuracy. Confidentiality is assured on all projects. All of our processes meet or exceed regulated quality standards; and, by meeting ISO standards for our quality management system, we show our commitment to customer satisfaction with flawless products and service.

SmartScope Quest 650

To print or download a copy of our ISO certifications, please select: ISO 9001:2008 or ISO 13485:2003 & EN ISO 13485:2012.