Microprecision Medtech Manufacturing of Medical Devices, Components, and Implants
Norman Noble, Inc. is widely referred to as the most technologically advanced contract manufacturer in the medtech industry. Our unique, vertically integrated micromachining and finishing capabilities enable us to manufacture the newest implant and medical device component designs for you. With every manufacturing run, we ensure the highest quality for your finished medical products through:
- Automated 100% dimensional inspection and complete process validation services per ISO 13485:2003 & EN ISO 13485:2012 (The international standard for medical implants and devices).
- FDA QSR 21 CFR Part 820 compliance to ensure the highest level of quality for your medical products.
Experience: Norman Noble, Inc. has been manufacturing products for the medical industry since 1946. Our team of more than 500 employees is fully committed to the manufacturing of medical devices and implants that are produced daily for our OEM customers. We specialize in micromachining of exotic materials to very complex geometries with dimensional tolerances to +/-.0001”. A few examples of the many types of medtech products that we manufacture using our specialized micromachining and automated finishing technologies include:
- Cardiovascular Stents
- Heart Implants and Devices
- Neurovascular Stents
- Vessel Closure Implants
- Multi Leaf Collimator (MLC) Assemblies for Tomographic Therapy Equipment
- Spinal Implants
- Orthopedic Screws and Plates
- Catheter-based Delivery Systems and Components
- Neurovascular Devices
- Maxillofacial Screws and Plates
Unique Capabilities: Norman Noble, Inc. is the leader in applying the newest technologies available for medical implant machining. We also develop proprietary technologies including:
- Laser welding of dissimilar materials
- Square Corner Electropolishing
- Athermal laser machining using Noble S.T.E.A.L.T.H. SM (System To Enable Ablation Laser Technology Haz-free)
- Millennium Focus laser cutting
- Electropolishing & Shape Setting of Nitinol
Examples of the many exotic materials we have used to manufacture components include:
Norman Noble, Inc. provides customers with the highest level of quality required for medical products. Our quality system is registered to ISO 13485:2003 & EN ISO 13485:2012 (The international standard for medical devices and implants) and offers full process validation services per FDA QSR 21 CFR Part 820, through our quality engineering team to support all aspects of our manufacturing capabilities.
Our process validation department works to meet customer requests and provide IQ/OQ, MSV, PQ/PPQ, TMV, DOE, and risk analysis to satisfy product requirements. Exceptional capabilities, experience and understanding of the industry are the reasons Norman Noble, Inc. continues to be recognized as the leader in microprecision machining for the medical device industry.
Prototype Through Production: From initial prototype through all steps of FDA approval and full production requirements, we can support the manufacturing of your component or implant. Our experienced engineering team develops the manufacturing processes to provide the most cost-effective, highest quality products, while our proprietary manufacturing and finishing technologies enable customers to bring products to market where production might otherwise be cost prohibitive or constrained by manufacturing limitations.
Requests for quotations on all medical device manufacturing services can be emailed to firstname.lastname@example.org or submitted on our RFQ page.