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ISO 14971:2012 Med. Devices - Risk Management Assessment


The requirements contained in ISO 14971:2012 provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.

This International Standard was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this International Standard could be used as informative guidance in developing and maintaining a risk management system and process.

This International Standard deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment.

As a general concept, activities in which an individual, organization or government is involved can expose those or other stakeholders to hazards which can cause loss of or damage to something they value. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity.

It is accepted that the concept of risk has two components:

The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.

All stakeholders need to understand that the use of a medical device entails some degree of risk. The acceptability of a risk to a stakeholder is influenced by the components listed above and by the stakeholder’s perception of the risk.

A risk management file is an integral part of any medical devices’ technical documentation because it details the hazards and risks linked to the use of a device and how the manufacturer handled them in order to optimize its safety and performances. Manufacturers usually construct the risk management file by continuously analyzing the risks of their devices throughout the devices’ design and development stages.

This harmonized standard, which may be adopted on a voluntary basis, can consistently help a manufacturer clarify and implement the regulatory requirements of the Medical Devices Directives.

The Importance of Risk Management

The inherently risky nature of medical devices, especially those that come into contact with critical systems, means that manufacturers must thoroughly analyze their devices’ risks against many factors. Before analyzing risks, manufacturers make a risk management plan to implement the risk management process throughout the life-cycle of their device.

Med. Devices - Risk Management Assessment

Medical Devices - Risk Management Assessment


In the medical device industry, risk management goes beyond development and manufacturing; it is a vital part of all your company’s processes. ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.

Manage risk effectively and see business success with ISO 14971

With ISO 14971 compliance, your risk management system will be optimized from product conception to research and development and production, and through post-market surveillance, product decommissioning, and safe disposal.

The primary focus of Medical Device Risk Management is minimizing risk to patients and caregivers. However, the manufacturer must also consider other stakeholders, including third party payers, the environment, reputation, and industry standing. To support this comprehensive approach, risk management must be integrated into the manufacturer’s Quality Management System and the Design Control process..


Some of the key benefits are listed below:


Steps to ISO/IEC 13485:2012 certification

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9001 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. Thus it is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

The Importance of ISO 13485

ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers can enhance an organization's marketability as more and more manufacturers require certification in order to do business as a vendor.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control, and maintenance of your quality management system is critical to customers, stakeholders, and regulatory agencies

The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit of the system to test the effectiveness of the system. It provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements.