Quick Tip: Build a strong link between clinical evaluation and risk management
Understand interfaces, synchronize activities, and collaborate to achieve both scale and efficiency in your clinical evaluation process.
Clinical evaluation of medical devices is now more important than ever, especially because of a strong emphasis in EU-MDR, the revised medical device regulation in the European Union.
Many manufacturers of medical devices are challenged to comply with new requirements for clinical evaluation. One source of confusion is a lack of definition and understanding of the term “clinical risk”.
Generally speaking, industry practice of risk management is driven by an engineering approach which focuses primarily on risks arising from potential device failures.
Clinical evaluation, on the other hand, focuses on evaluating risk(s) of harm in the clinical environment and provide evidence of continued safety and effectiveness of a medical device.
In principle, the clinical evaluation process should connect and align with the risk management process to ensure that all risks associated with the intended use and foreseeable misuse are identified early in the design and development process. However, this interface is generally not well-defined in the industry. Interfaces with other processes such as usability and post-market surveillance are also not well-defined.
That is why, building a strong link to the risk management process is important to gain both scale and efficiency in the clinical evaluation process. It helps to build a solid understanding of relevant interfaces and synchronize various activities in the risk management process. Risk management intersects with different processes within the quality management system and requires working collaboratively with subject matter experts from different functions. We all have to get involved in the process, break the silos, talk more and collaborate more for success.
