Medical devices technical performance

Coordination of outside engineering and technical services performed by vendors Training of medical personnel in the safe and effective use of medical devices and systems Clinical applications engineering, such as custom modification of medical devices for clinical research, evaluation of new noninvasive monitoring systems, etc. 

Self-regulation is usually only effective when it concerns a product that is relatively simple to describe and to provide, with widely accepted standards regarding its safety performance (e.g., aviation), or when it concerns a product that is not allowed onto the market unless it has successfully passed various process stages by responding adequately to laws of certainty and predictability and technically engineered solutions (Freed et al, 2001). Medical device manufacturing, medical device application, and patient safety are not such simple issues. Past... 

The current Japanese guidance document, titled Test Methods for Biological Safety Evaluation of Medical Devices, Assessment of Medical Device, Notice 36,2003, partially embraces ISO 10993, but it has technical specifications to perform tests that differ from the procedures specified in ISO 10993. As a consequence, many Japanese regulators do not readily accept testing conducted according to ISO 10993. Such reluctance will likely to continue until the techifical sections of these two standards are harmonized. At present the techifical conduct of many studies differs enough for the end point requirements of a Japanese test to be different from the requirements of ISO, and vice versa. Additional testing may thus be required to submit a medical product for Japanese approval. 

Any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to above, leading to systematic recall of devices of the same type by the manufacturer. 

Biopolymers are often used throughout the human body they are also called biomedical polymers. A biomedical material can be of natural origin (biopolymer) or a synthetic polymer and can be used for any period of time, as a whole or as part of a system that treats, augments, or replaces any organ or function of the body, as well as for medical technical applications outside the body. When a prosthetic device is placed into the body, two aspects must be taken into account functional performance and biocompatibility. The former requires special functions of the biomedical polymers, in particular including load transmission and stress distribution. Biocompatibility between a polymer and a biological system (e.g., soft tissue,... 

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