Get approval with conform risk management process

ISO 14971 is the international accepted standard for risk management of medical devices.  We will support you in creating ISO-14971-compliant risk management file and developing safe products.

MedSysCon offers support for:

  • Implementation of a conform risk management process
  • Implementation of DIN ISO 14972
  • Risk analysis, -evaluation and –control
  • A periodic risk evaluation of your medical devices on the market
  • Remediation of existing risk management files
  • Moderation of risk management meetings

ISO 14971

ISO 14971 demands the identification of hazards by a risk management process for manufacturer of medical devices and accessories. In a second step the risks must be evaluated and measures have to be described to minimize the risk and to surveil efficacy. These requirements are valid for all stages of the product’s life cycle. Even after market release they must be monitored.

Risk management is not only essential part of development, but also part of production and post-production phases of medical products. MedSysCon supports you in creating and implementing a risk management process, according to ISO 14971. During implementation together we determine adequate acceptance criterions for your product. We will also guide you in identifying hazards and assessing risks and will support you in risk control and risk-benefit-analysis.

Additional Requirements for medical devices

There are legal and normative requirements referring to the risk management. These requirements also must be fulfilled besides the distinct requirements of ISO 14971.

ISO 14971

Risk Management according to the accepted standard

Interfaces

Internal and external interfaces in the risk management process

Your Benefits

The risk management files is key. There is no other document more often rejected. We will support you in creating a fully ISO 14971 compliant risk management file.

Do you have questions on the subject Risk Management?

We will be happy to provide you with comprehensive advice.

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