As an industry leader in the contract manufacturing of medical devices and nitinol implants, Norman Noble offers the most advanced technologies to customers, including fully automated passivation and fully automated & validated final cleaning processes.
Norman Noble’s cleaning validation documentation: Strategy, IQ, OQ and PQ, have been completed in a format that can be shared with customers and includes a matrix of small to large part sizes, shapes and geometric complexities produced from many medical implant material grades. This allows customers to review the validation process, documentation and test results in detail. Norman Noble’s customers can compare this information to their current or proposed cleanliness specifications. In many cases this gap analysis will show the Norman Noble cleaning validation process fully satisfies customer requirements for specification and regulatory compliance.
Our new Elma cleaning line and shareable validation reports help simplify our customers’ submission and compliance with Regulation (EU) 2017/745 of the European Parliament and are designed to support meeting the requirements of Annex II.
Norman Noble’s advanced systems improve productivity, product quality, product consistency, operational safety and reduction of environmental waste. For more information, download our Passivation & Cleaning white paper.
Facts at a Glance:
- Cleaning Validated per ISO 13485:2016
- Automated cleaning and automated passivation
- Residual materials, particulate size analysis, cytotoxicity, total organic carbon, endotoxins, corrosion resistance
- Cleaning validation according to ASTM F3127
- Elma cleaning line meets EU MDR requirements (EU) 2017/745
Materials and Applications
Vascular Stent Implants:
AAA Stents (Abdominal Aortic Aneurysm)
BTK (Below The Knee)
Transcatheter Heart Valve Implants and Frames:
Left Atrial Appendage Closure
Neurovascualr Clot Retrieval Devices
Embolic Filters Arterial Closure Implants
Atrial Fibrillation Devices
Vena Cava Filter Implants
Renal Denervation Devices
Spinal Implants and Devices
Extremity Screw and Plate Implants and Devices
Ligament Repair Anchors and Devices
Stainless Steel Alloys
High Nickel Alloys