ISO 14971 – Requirements on risk management for medical devices

ISO 14971 demands a risk management process of manufacturers of medical devices and accessories to identify hazards, to evaluate risks and to describe measures to minimize risk and to surveil their efficacy. These requirements apply for all stages of the product’s life cycle. Due to this they have to be monitored even after putting the product on the market.
Risk management is not only an essential part of development, but also part of production and post-production of medical products. Benefit from the longstanding Experience of our experts and risk managers.
PROSYSTEM supports you in creating and implementing a risk management process, according to ISO 14971, by issuing standard operating procedures, working instructions and form sheets. During implementation our specialists determine adequate acceptance criterions for your product with your cooperation. They will also guide you in identifying hazards and assessing risks and they will support you in risk control and risk-benefit-analysis. Furthermore our experts consider international “Technical Reports” and “Guidelines” such as ISO/TR 24971, IEC/TR 80002-1 or ISO/IEC Guide 63.
In 2012 the current version of EN ISO 14971 was published. It differs particularly from earlier version due to annexes ZA, ZB and ZC. In these annexes the relation between EN ISO 14971 and EU-Directives 93/42/EEC, 90/385/EEC and 98/79/EC gets clarified.
As an active member of the international standardization group for ISO 14971 we offer you detailed up-to-date background information first-handed. Due to this PROSYSTEM is able to adapt to the latest developments and requirements. This enables our customers to adjust to these information, to update their projects and thus to prevent later afford.