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Risk management

Risk management

DIN EN ISO 14971:2019 is a new standard for risk management for medical devices. Its aim is to create a consistent approach to the process, which ensures that the risks associated with a medical device are appropriately managed. However, the new standard will have different implications for manufacturers of different products. This article will explain the differences between the new standard and the previous edition. The purpose of this document is to help you understand and apply the latest risk management guidelines for medical devices.

BS EN ISO 14971 is applicable to all phases of the lifecycle of a medical device. It does not prescribe risk levels or define what levels are acceptable. The standard does not require the use of a quality management system, but it can be part of it. Because the standard is designed for medical device manufacturers, it uses well-established principles of risk management. While it requires manufacturers to develop a quality management system, it should be viewed as an informative guide and not as a regulatory requirement.

Moreover, the new European EU MDR and IVDR also require manufacturers to implement a quality management system that incorporates risk management. To meet this requirement, manufacturers must develop an appropriate quality management system. While it does not mandate a quality management system, risk assessment should be part of it. In the long run, risk assessment and mitigation will be the key to a successful outcome. It is important to note that these regulations are not yet included in DIN EN ISO 14971, but are intended to be informative and useful for manufacturers.

DIN EN ISO 14971:2019 is a new standard for risk management in medical devices. It outlines a process for assessing and controlling risks in medical devices. The standard is based on the European Commission's mandate. The standard's 10 clauses and three annexes outline a process to assess the risks associated with a medical device. Once implemented, this international standard is expected to be a European harmonized standard.

The International Standard describes a process that medical device manufacturers should follow in evaluating, controlling, and monitoring risks. It specifies the steps for a medical device's development. A risk-benefit analysis should be conducted to evaluate the risks. Managing and implementing a quality management system is vital for ensuring the safety of medical devices. It should not replace solid design controls, but they do benefit the product.

The international standard for medical devices, ISO 14971, focuses on risk management. It is a comprehensive standard that provides guidelines for the process from identifying risks to identifying and mitigating them. It should include the operational risk management process, cyclical review, and a continuous evaluation of the plan. For example, a medical device supplier must develop a comprehensive risk management plan that minimizes the impact of risks on the design and effectiveness of the product.

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