Medical Device Software Validation and Risk Assessment
Medical Device Software Verification
Compared with the IEC 62304 standard developed by the United States and the European Union, as a reference for the basic implementation of software validation, there are many items in the software lifecycle management related to the ISO 13485 software validation process, which are mainly divided into “software development” and “Software Risk Management” are described below. First, determine the general structure of the software, then pass the software unit verification, software integration test, and system test, and then release the software. Each step in the process must include the steps and processes as a result, documents are kept for records, and the program security is divided into three levels of A, B, and C according to the degree of harm to the human body when an error occurs, and the requirements of the documents are also different.
(1) Software development process:
(1-1) Software Development Planning (SW DM Plan)
(1-2) Software Requirements Analysis (SRS)
(1-3) Software Architectural Design (SAD)
(1-4) Software Detailed Design (SDD)
(1-5) Software Unit Implementation & Verification
(1-6) Software Integration and Integration testing
(1-7) Software System Testing
(1-8) Software Release
(2) Software risk management process:
In addition to the software development process, the risk management process is also very important. It is necessary to evaluate the various accidents that may occur and list them, and calculate the probability that may occur and estimate the degree of possible damage. After the comprehensive assessment, the degree of risk is numerically quantified come out. If the risk is too high to be fatal, additional control measures must be added to reduce the probability of the accident or the degree of damage, and reduce the degree of risk to an acceptable range.
Risk Assessment
With the continuous update of ISO 13485 and EU medical device regulations in recent years, the risk management standard ISO 14971: 2019 has been officially issued. The medical device quality management system and EU product registration directives are required to be implemented during the product realization and risk management. How to effectively identify, assess and control risks. Plan to implement the risk management of the actual implementation of the company’s processes, which is not only meets the regulatory requirements of health authorities, but further uses this tool to avoid the damage caused by the accumulation of excessive risks, and more effectively promotes the benefits of companies and products. Aspects need to be documented in detail to demonstrate that the manufacturer is committed to controlling risks throughout the design of a particular medical device, including:
(1) Risk Analysis
(2) Risk Evaluation
(3) Risk Control
(4) Evaluation of Overall Residual Risk
(5) Risk Management Review
(6) Production and Post Production Activities