The fourth edition of IEC 60601-1-2 has been approved, and this means dramatic changes for the medical device industry. This edition introduces new product categories, new test levels, and eliminates the “life-support”...
Case Study - Equator™ gauge: “As Quality Manager, it has quickly become the best investment we’ve made.”
David Powell, Quality Manager at UK-based Euromould Ltd, has been using Renishaw’s Equator flexible gauge to increase inspection capacity and portability, achieving an 85% reduction in the inspection time of injection...
Free whitepaper focusing on how to choose illumination systems that produce the best imaging results.The illumination used for microscopic observation has a very important effect on the final image quality. Choosing the...
As a means to ensuring the safety of sterile products, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have provided strict guidelines for the testing of container closure systems....
For quality assurance, the weld of a ring-welded specimen is tested with the help of light microscopy. Compared to investigations with conventional light microscopes, the digital microscope Smartzoom 5 significantly...
Medical-device makers like Spacelabs Healthcare are under pressure to offer more features, increase automation, and get long-term value from their test equipment.That’s where Averna came in. With its deep RF and...
Medical devices are required to be tested for leaks or imperfections, and many OEMs are unsure as to what is the best medium for testing—air or water? The two modalities are not equivalent, and although testing with...
Platform testing medical devices in the manufacturing stage can help manage costs, access, and coverage
The updated “EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices” standard was published August 30, 2012 in the Official Journal as harmonized to the Medical Device Directive, Active...
Temperature affects are a significant consideration when testing for leaks when using pressure or flow measurement techniques. These are two sources of temperature effects; adiabatic, the effect of changing the pressure...
This article describes the challenges and successes in which a modern, non-contact technology replaced older manual methods. Four scenarios are discussed in which this newer technology can be integrated into a company’s...
The auto-injector is becoming an ever more popular choice for patients and doctor wishing to replace the traditional injection method. However, the manufacturers themselves require lengthy iterations in the design...
Orthopedic manufacturers are always looking for ways to expedite product design and revision. They would also like to refine their processes according to contemporary form-centric design principles. The story of...