Metrology for Medical Manufacturing

Metrology for the Medical Field: Ensuring Precision in Medical Manufacturing

Medical device manufacturing demands stringent quality assurance and inspection processes. Products often serve critical roles, such as being implanted into the human body, making precision and compliance with regulatory standards essential. With oversight from organizations like the U.S. Food & Drug Administration (FDA) and Health Canada, medical device manufacturers must adhere to strict quality and safety measures to protect patient health.

Challenges Facing Medical Manufacturers

Regulatory Compliance: Meeting FDA/Health Canada requirements for documentation and validation of measuring systems is a significant hurdle.

Reluctance to Modernize: Many manufacturers continue to use legacy inspection methods, even as new technologies with better throughput and accuracy become available.

High Inspection Rates: The medical industry often requires 100% inspection of components, demanding reliable and efficient measurement systems.

Time-to-Market Pressures: Manufacturers need to streamline processes to reduce delays while maintaining accuracy.

Advanced Metrology Solutions for Medical Manufacturing

To overcome these challenges, cutting-edge metrology solutions offer unparalleled accuracy and reliability throughout the manufacturing process—from design to final production. Our metrology services provide the tools necessary for precision measurement in even the most complex medical applications:

Our Solutions Key Applications

Orthopedic Devices: Knees, hips, and shoulder implants require precise dimensional measurement to meet rigorous standards.
Drug Delivery Systems: Automated devices like insulin pens and epinephrine autoinjectors benefit from non-contact measurement methods.

Advanced Metrology Technologies:

Coordinate Measuring Machines (CMMs): Essential for qualifying robotic and prosthetic components.

Laser and White Light Scanning: Provides rapid, high-accuracy non-contact measurements for intricate designs.

Benefits of Metrology in Medical Manufacturing

Regulatory Compliance: Meet and exceed FDA/Health Canada standards with validated measurement systems.

Reduced Costs: Minimize waste and rework by catching defects early in the production cycle.

Improved Speed and Accuracy: Streamline quality assurance processes to reduce time-to-market.