New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
Quality is the most common offshore problem cited by companies who have reshored to the U.S. As reshoring in U.S. manufacturing continues to grow, total cost of ownership (TCO) analysis remains a key, underutilized tool that companies can use to make the best sourcing decisions.
Many new industries are employing 3D scanning not only to create 3D models of parts or products for reverse engineering but also to explore the composition and rapid production of ready-to-use parts via 3D printing.
The scope of product testing is growing broader and more complex. Traditionally, the objective was to confirm compliance with relevant safety regulations. But today we’re seeing more product management teams also push for functionality and reliability testing.
Hand tools are the workhorse of the industry. Every metrologist has a variety of hand tools in his toolbox. You’re sure to find one, two or several micrometers in that toolbox to accurately measure thickness, outer and inner diameters, as well as depth of slots.