Risk Management for Medical Devices and In Vitro Diagnostics <\/h2><\/h2><\/div><\/p>\nThere 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><\/p>\n<\/div><\/div><\/div><\/div><\/div>
The procedure according to ISO 14971<\/h3><\/h3><\/div>ISO 14971 pertains to the field of medical technology and is titled \u201cMedical devices\u2014Application of risk management to medical devices.\u201d It describes risk management and is applicable internationally.<\/p>\n
The internationally recognized ISO 14971 standard specifies the following procedure:<\/p>\n<\/div>
- <\/i><\/span>\n
\nHazards posed by the medical device or its accessories must be assessed, evaluated, and controlled.<\/p>\n<\/header><\/div>\n<\/div><\/li>
- <\/i><\/span>\n
\nEffectiveness must be monitored through controls.<\/p>\n<\/header><\/header><\/div>\n<\/div><\/li>
- <\/i><\/span>\n\n
\nThe requirements of the standard apply during all phases of the product life cycle of a medical device.<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
If these risks are not identified and eliminated in a timely manner, this can have far-reaching consequences. Under the Medical Devices Act and the Medical Device Regulation (MDR), risk management is <\/span>a mandatory requirement<\/span>.<\/span><\/p>\nOur 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>
From the Field: Projects That Make a Difference<\/h2><\/h2><\/div>How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.<\/p>\n<\/div><\/div><\/div>
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><\/p>\n<\/div><\/div><\/div><\/div><\/div>
The procedure according to ISO 14971<\/h3><\/h3><\/div>ISO 14971 pertains to the field of medical technology and is titled \u201cMedical devices\u2014Application of risk management to medical devices.\u201d It describes risk management and is applicable internationally.<\/p>\n
The internationally recognized ISO 14971 standard specifies the following procedure:<\/p>\n<\/div>
- <\/i><\/span>\n
\nHazards posed by the medical device or its accessories must be assessed, evaluated, and controlled.<\/p>\n<\/header><\/div>\n<\/div><\/li>
- <\/i><\/span>\n
\nEffectiveness must be monitored through controls.<\/p>\n<\/header><\/header><\/div>\n<\/div><\/li>
- <\/i><\/span>\n\n
\nThe requirements of the standard apply during all phases of the product life cycle of a medical device.<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
If these risks are not identified and eliminated in a timely manner, this can have far-reaching consequences. Under the Medical Devices Act and the Medical Device Regulation (MDR), risk management is <\/span>a mandatory requirement<\/span>.<\/span><\/p>\nOur 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>
From the Field: Projects That Make a Difference<\/h2><\/h2><\/div>How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.<\/p>\n<\/div><\/div><\/div>
ISO 14971 pertains to the field of medical technology and is titled \u201cMedical devices\u2014Application of risk management to medical devices.\u201d It describes risk management and is applicable internationally.<\/p>\n
The internationally recognized ISO 14971 standard specifies the following procedure:<\/p>\n<\/div>
- <\/i><\/span>\n
\n Hazards posed by the medical device or its accessories must be assessed, evaluated, and controlled.<\/p>\n<\/header><\/div>\n<\/div><\/li>
- <\/i><\/span>
\n\n Effectiveness must be monitored through controls.<\/p>\n<\/header><\/header><\/div>\n<\/div><\/li>
- <\/i><\/span>
\n\n\n The requirements of the standard apply during all phases of the product life cycle of a medical device.<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
If these risks are not identified and eliminated in a timely manner, this can have far-reaching consequences. Under the Medical Devices Act and the Medical Device Regulation (MDR), risk management is <\/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>
From the Field: Projects That Make a Difference<\/h2><\/h2><\/div>
How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.<\/p>\n<\/div><\/div><\/div>
- <\/i><\/span>
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