ISO 14971 is the international standard for risk management in medical devices, and at confinis, we help clients implement its principles effectively. Our services include developing risk management plans, conducting risk assessments, and implementing risk control measures. We ensure that all potential hazards are identified, evaluated, and mitigated throughout the product lifecycle.

Our team provides training and support to help clients integrate risk management into their quality management systems. By following ISO 14971, we help clients ensure that their products are safe, effective, and compliant with regulatory requirements. This systematic approach to risk management reduces the likelihood of adverse events and enhances overall product quality.