The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management medical devices and steps to implement it during the product development stage.
Companies are usually faced with challenges to make the medical devices safe for human use, ensuring they are effective. For that matter, when it comes to designing and developing medical devices, companies must comply with FDA and ISO quality systems regulations to ensure they are risk-free.
These FDA QS regulations and ISO 14971 device quality system requirements address processes and procedures for post-product development, which broadly outline the processes involved in risk management medical devices.
What is risk management in medical device?
Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators, or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product.
ISO 14971:2007 specifies and regulates the process to be followed by the medical device manufacturers to avoid the possible hazards associated with the device.
Like ISO 14971, there are many other regulations that specify risk management steps during the development of medical devices. The approach of these could be different, but the goal is the same.
Steps Involved in Risk Management for Medical Devices
There are various policies, procedures and practices used to analyze, evaluate, control, and monitor risks systematically in medical devices. Let us understand the standard steps to implement a thorough risk management lifecycle for medical devices:
01. Framework & Planning for Risk Management Medical Devices
Defining any risk management process in compliance with the regulations like FDA or ISO needs to be established by a risk management framework. This framework includes the process which will be used to develop the device, as well as the roles and responsibilities of people associated with the device development project. Along with this, a proper documentation of the risk management plan is also required to be established as a part of the framework for risk management in medical devices.
Compliance with #FDA QS and #ISO14971 is necessary for developing risk-free #MedicalDevices @einfochipsltd
02. Risk Analysis
Medical device risk assessment will help the device manufacturers direct their efforts towards defining the intended use of the product. This will help in focusing on the necessary steps, overviewing the relevant hazards (potential sources of harm).
During this stage, the foreseeable hazards need to be identified as early as possible for assessing the risk. It is interesting here to note that while assessing risks, the process of identifying potential harms should not only consist of finding the causes but also the potential risk related to them.
03. Risk Evaluation
Identifying severity and occurrence (probability) of risks will help in quantifying and evaluating the risk. Suppose there is a hazardous situation (very likely to occur), but with low harmful effects and there is another situation where the possibility of harm is very high, then proper visualization of the risk on a matrix is a good idea for deciding which hazard needs to be tackled first.
04. Risk Control
Once the risk has been identified, the next step is to control the risk, where the actual implementation of risk mitigation takes place. The aim of risk control is to mitigate or lower the intensity of risk to an acceptable level.
There are several ways to mitigate or control a risk:
One way it can be done is by changing the design of the product to a level where the risk is mitigated, but that’s not always possible. The next option is to integrate protective measures in accordance with a particular risk and decrease the occurrence of harm. The last thing is labeling or adding instructions in the device manual regarding the risks involved in a particular device.
It’s also important to note that by redesigning the product for the sake of risk control, there are chances that more risks can be added to the product.
05. Reports and Documents
The last and the most important step is to document the risk management plan and strategies. It is also important to note that, documenting the risk management plan is not limited to initial stages.
The risk management document must contain all the actions, reports, assessments, and diagrams created for the risk management planning process.
Since the risk management plan is a part of whole product development lifecycle process, your documents should be up to date even after the completion of the product development process.
Along with this, it’s also important to document the effectiveness of the control actions, keeping an eye on the resulting risks after implementing the risk control actions.
Risk Management Software Medical DevicesAs more devices have incorporated the software risk management is required to be planned and strategized in the early stage. Healthcare industry has medical devices that manage critical situations including diagnostics patient monitoring and therapeutic. Operating software on top of the device hardware continues to be key factor for deciding how many devices will be functioned.
Even the solutions that has all the functions including electronic and mechanical software can consume major time in the development cycle. Devices with straight forward use case will have simpler user interface will be quick to design and easy to deploy. The growth of software in medical will also increase the risk associated with that due to data breach and open access. Whether it is legacy medical devices or software as a medical device, risk management is the key principle that defines the regulation of the medical equipment. While regulatory framework will have many standards, risk management connects all these standards and as a part of regulatory. ISO 14971 outlines important principles of risk management software medical device that covers all the required regulations and standards – covering both legacy devices and software as a medical device (SaMD). However, in case of software, there are unique considerations for risk management as it involves rapid cycles of development and change.
Above are the steps that are crucial in the medical device product development cycle. Achieving compliance through adequate evaluation of the risk management cycle helps develop the product with desired quality and safety standards.
eInfochips has hands-on engineering experience in developing FDA Class 2 and Class 3 devices for monitoring, diagnostics & imaging, wearable health, and telemedicine. We provide HIPAA compliant engineering solutions and have the required process expertise in IEC 60601-1/2/6, IEC 62304, 510K and ISO 13485. Know more about medical devices engineering services.