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...
The SECULIFE IA is ideally suited for demanding illumination analysis in the field of medicine, for example approvals and consistency testing, as well as luminance measurements at image viewing devices for computer...
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...
The International Electrotechnical Commission, or IEC, has done the industry a great service by introducing a series of standards for the safety and efficacy of medical electrical equipment, better known as IEC 60601....
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...