Cleaning & Finishing
As part of our unwavering dedication to quality, Norwood Medical’s facilities are equipped with the processes, technologies, and trained professionals to ensure that each and every medical device is produced at the highest standards. Here are some of the ways Norwood Medical maintains our high- quality standards with cleaning and finishing processes:
Quality inspection stations
Dedicated manual inspection stations are in place at each of our production facilities. There, employees inspect each part with microscopes and other inspection tools, and are trained to recognize and remove the slightest imperfection or debris. Other stations requiring more sophisticated inspection rely on a combination of computer-based mechanical evaluation and manual measurements to precisely inspect the geometry of each part to ensure its integrity.
Krytox and sodium stearate coating
Krytox and sodium stearate (soap) coatings are used in the finishing process to provide a protective seal on a metallic medical device or component. The process ensures that the resulting coating remains adhered to the metal surface, even under extreme duress or deformation.
Ultrasonic cleaning systems are used to thoroughly remove all traces of contamination that may be adhering to or embedded onto a medical device surface. Possible contaminants include a variety of materials that the component may have been exposed to during the manufacturing process. Ultrasonic cleaning can be used for a wide range of medical device shapes, sizes and materials.
Norwood Medical performs passivation as a surface-finishing process on stainless steel components. Norwood Medical’s passivation process is a natural, environmentally friendly method to remove tiny particles and make them resistant to future corrosion.
Cleanroom assembly and packaging
Norwood Medical is equipped with ISO Class 7 (10,000) cleanrooms to perform assembly and packaging without any environmental contaminations. Maintaining the highest medical device standards for our customers is our greatest commitment, and Norwood Medical’s cleanroom service is one of the many ways we accomplish this goal.
Minimally Invasive Surgical
Norwood Medical partners with the industry’s leading medical device suppliers to aid in the progress of minimally invasive surgery. From wound closure to general surgery, we help our customers create devices that are secure and effective for a variety of procedural needs:
- Surgical Cutting and Stapling Components
- Clip Applier Components
- Harmonic Device Components
- Linear Cutter Components
- Cannula Components
Dedication to Quality
Norwood assures customer satisfaction and product safety through a robust and proven Quality System. We recognize that there is no place for implants, instruments or procedures that don’t meet the very highest quality standards
- 21 CFR 820 FDA Quality System Regulation (QSR) compliant and ISO 13485:2003/ISO 9001:2008 certified
- Deploying ASQ Certified Six Sigma Black Belt Staff
- Utilizing ISO 14971:2007 risk management system for medical devices