title: [Biological evaluation within a risk management process].
abstract: Bio-evaluation within the medical device quality/risk management system is a risk analyzing and assessing process. On the basis of data from characterization of materials, scientific literatures, application history, bio-toxicology testing and so on, weighing the benefit and the risk, bio-evaluation does a conclusion to "take" or "quit" the product design. There is no "zero risk" though "no toxicity" always is the most desirable conclusion in a testing report. The application history data is the most comprehensive among the information available, since no testing system can "clone" the human body. In addition, the capital cost has to be taken into account when bringing the sophisticated testing technologies into the evaluating system. Investigating the #G95-1 of FDA CDRH and the changes of ISO 10993-1, the trend to integrate bio-evaluation into a quality/risk management process can be figured out.
authors.affiliation: Shanghai Testing & Inspection Institute for Medical Devices.
authors.forename: Fei
authors.initials: F
authors.lastname: Zhuang
authors.forename: Biao
authors.initials: B
authors.lastname: Ding
mesh_terms: D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D011786:Quality Control; D012308:Risk Management