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There is a particularly high level of protection, which is why the remaining residual risk must be weighed against the benefits of the product. German, European and American legislation for medical devices all require risk management for medical devices and in-vitro diagnostics.<\/p>\n
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ISO 14971 is assigned to the medical technology sector and is entitled \u201cMedical devices \u2013 Application of risk management to medical devices\u201d. It describes risk management and is internationally applicable.<\/p>\n
The internationally valid ISO 14971 standard specifies the following procedure for this:<\/p>\n<\/div>
Hazards from the medical device or accessories must be assessed, evaluated and controlled.<\/p>\n<\/header>\n<\/div>\n<\/div><\/li>
Effectiveness must be monitored through controls.<\/p>\n<\/header>\n<\/header>\n<\/div>\n<\/div><\/li>
The requirements of the standard apply during all phases of the product life cycle of a medical device.<\/p>\n<\/header>\n<\/header>\n<\/div>\n<\/div>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
If these risks are not promptly identified and eliminated, this can have far-reaching consequences. According to the Medical Devices Act and the Medical Device Regulation (MDR), risk management is mandatory for all medical devices. <\/span>a mandatory requirement<\/span>.<\/span><\/p>\n Our risk management service portfolio is designed to support manufacturers in precisely meeting international standards and regulations. From extensive planning and risk assessment to the implementation of effective risk minimization strategies, we support our customers throughout the entire product life cycle.<\/p>\n<\/div><\/div><\/div><\/div><\/div>