Risk Management in Medical Equipment
Risk management is an essential element in the manufacturing of medical equipment. The ISO 14971 standard provides a comprehensive framework for identifying, assessing and controlling risks associated with these devices throughout their life cycle. This process ensures that products are safe and effective, protecting both patients and healthcare professionals.
Implementing a robust risk management system begins with identifying all potential hazards. This includes considering normal conditions of use as well as potential failure scenarios. Manufacturers must assess the likelihood of occurrence and the severity of the consequences of these hazards to determine risk levels.
The ISO 14971 standard guides the application of appropriate controls to mitigate the identified risks. These controls may include changes to the product design, additional safety measures or specific instructions for use. The goal is to reduce risks to acceptable levels without compromising the functionality of the device.
At PCN Latin America, we offer certification services that include a detailed analysis of risk management processes. Our approach ensures that devices meet the highest safety and quality standards, providing confidence to manufacturers, users and regulators such as Inmetro - National Institute of Metrology, Quality and Technology and ANVISA.
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