International Approval – International Market Strategies for Medical Devices

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

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.

Dr. Alexander Theis

Dr Alexander Theis
Senior Manager Regulatory Affairs – Medical Devices

Tel: +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.

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 national and European 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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