ISO 14971 – Risk Assessment of Medical Devices

The requirements defined in ISO 14971 are complex and many questions can arise during a risk assessment when performed by medical and technical experts.

When it comes to the performance and safety of medical devices, the requirements vary depending on the nature of the device in question and intended purpose of use. Stipulations go far beyond the requirements regarding design and manufacturing. Manufacturers are also required to establish, implement, document and maintain a risk management system. It is obligatory that any risks that may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. Furthermore, it is necessary to reduce risks as far as possible without adversely affecting the benefit-risk ratio.

Our risk management services at a glance

  • Preparation of procedural instructions for implementation of risk management policies and activities
  • Providing risk management forms in line with the newest ISO 14971 and ISO/TR 24971 including customised support
  • Moderation of risk assessment team meetings
  • Support with specific questions and deviations
Dr. Alexander Theis
Dr Alexander Theis
Senior Manager / Team Lead
Technical Documentation and Regulatory Affairs, Medical Devices

Phone: +49 671 29846-177

We support you in setting up a risk management system

Contact our experts if you have questions with respect to risk analysis while you are planning to develop medical devices, preparing to place them on the market or considering a risk assessment update.

Our Services at a glance

Risk Management Standards

The risk assessment procedure is defined by ISO 14971, whereby risk management is a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. The requirements defined in ISO 14971 are quite complex. Formal questions often arise during a risk assessment when performed by medical and technical experts.

Risk Assessment Implementation and Moderation – Your Benefits​

SCC helps implement risk management in line with ISO 14971 in your quality management system and moderates risk assessments of your medical devices.

With our expertise at your disposal, you will benefit from:

  • Setting up procedures that are in line with all requirements and have a broad international acceptance
  • Enhancing cost and time efficiency of the assessment process
  • Obtaining valuable information enabling you to develop medical devices perfectly fitting users’ and patients’ requirements
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