Quality

Validated processes lead to quality
Quality

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 13485:2003/ISO 9001:2008 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 14971:2007 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.

Accreditations

Norwood Medical holds the following certifications and accreditations:

  • ISO 13485:2003 Medical Devices— Quality Management systems requirements for regulatory purposes — Registration # HQ-M-883
  • ISO 9001: 2008 Quality Management Systems Requirements— Registration # HQ-M-883  including Design
  • 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
Advancing Orthopaedic Care

Advancing Orthopaedic Care

We help companies advance the practice of orthopaedic care by manufacturing components, implants and instruments at the highest standards.
We manufacture medical devices for the following procedures:

  • Arthroscopic
  • Spinal
  • Trauma Surgery
  • Joint Reconstruction

To learn more about how our advancements in Orthopaedic Care, contact us today.

Minimally Invasive Surgical

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