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....
Over Molded and Encapsulated medical devices present a difficult challenge when investigating process issues or returns from the field due to the nature of their design. Visual inspection and electrical tests provide...
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...