Instructions for use and risk management: essential pillars of your medical devices’ safety

As central parts of the technical documentation, the risk management and instructions for use have to fulfill different normative requirements, e.g. ISO/EN ISO 14971 and requirements of the MDR (Medical Device Regulation (EU) 2017/745).

These documents are not only regulatory requirements, but also essential to ensure the safety and effectiveness of your products. A thorough risk analysis forms the foundation of risk management and guides the subsequent process. It integrates insights from clinical evaluation and post-market surveillance.

The instructions for use on the other hand is the direct way to communicate with your users and plays an integral role in the risk mitigation, by giving clear and comprehensive instructions for a secure use of the product.

At novineon CRO we support you extensively at handling these complex requirements. We objectively review your risk analysis and instructions for use for any inconsistencies and inaccuracies. We help you with creating or reworking of these documents.

Through a collaboration with novineon CRO you can ensure that your risk analysis and instructions for use are not only compliant with the regulatory requirements, but also efficiently integrated with the processes of the clinical evaluation and post market surveillance.

• We support you with harmonizing your risk analysis, instructions for use and clinical data.
• Our medical experts screen the clinical plausibility of your risk analysis and instructions for use.
• Benefit from our expansive experience and our individual support, from a formal review up to the collaborative creation of your documents.