Norwood assures customer satisfaction and product safety through a robust and proven Quality System that is 21 CFR 820 FDA Quality System (QS) Regulation compliant and ISO 13485:2016 certified. Norwood Medical understands that in the medical device industry, there is no place for implants, instruments or procedures that don’t meet the very highest standards of quality. We know that the quality of each one of our products will have a direct impact on a patient’s well-being, and because of this, we address quality with unwavering diligence.
At Norwood Medical, we believe in a comprehensive approach to quality process excellence, including:
- Validation of all special processes to ensure objective evidence that our product consistently meets the specified requirements utilizing IQ, OQ and PQ procedures
- Deploying certified Black Belt engineers using lean manufacturing/Six Sigma tools to eliminate waste and remove variation from our manufacturing processes
- Utilizing ISO 14971:2012 risk management system for medical devices to aid in risk management, including Process Failure Modes Effect Analysis (PFMEA), Design of Experiments (DOE), Process Capability Analysis and Control Plans
Quality metrology inspection laboratories
Each of our production facilities contains a dedicated Quality metrology inspection laboratory. There, certified inspectors perform detailed inspections, including first piece, last piece and in-process dimensional verifications to ensure product integrity. The laboratories are equipped with the latest metrology tools, which include CMMs, Optical Gaging Systems, Comparators, Hardness Testers and a host of mechanical inspection gauges.
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.
Norwood Medical holds the following certifications and accreditations:
- ISO 13485:2016 Medical Devices— Quality Management systems requirements for regulatory purposes
- ASQ Certified Staff— Six Sigma ASQ certified Black Belts, Green Belts, Engineers and Auditors
- GMP 21CFR820— Good Manufacturing practices for Medical Devices – Compliant Quality Management System
Medical Device Manufacturer
Norwood Medical focuses exclusively on medical device manufacturing. We have over 40 years experience helping customers deliver innovative products to market with speed and lean manufacturing practices.
- Vertically integrated to solve problems quickly
- Focused quality processes assure excellence
In an industry that demands the highest precision to ensure the safety and wellness of medical patients, Norwood Medical understands and accepts its critical role in this supply chain.
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 13485:2016 certified
- Deploying ASQ Certified Six Sigma Black Belt Staff
- Utilizing ISO 14971:2012 risk management system for medical devices
With an exclusive focus on medical device manufacturing, we offer a comprehensive range of capabilities to address the most complex customer requirements: