Gustav Sundström
Senior Consultant, Medical Device Quality Assurance – GBA Key2Compliance AB
The medical device industry holds patient safety as a top priority, but as devices grow increasingly complex, ensuring their safety demands more than just careful design—it requires a comprehensive approach. Today, medical devices rely heavily on both electrical safety mechanisms and medical device software (MDSW) to function reliably. Each of these components plays a critical role in delivering effective patient care and maintaining regulatory compliance.
Navigating the complexities of electrical safety and MDSW can be challenging, but with a structured, risk-based approach, manufacturers can streamline their compliance processes and avoid common pitfalls. In this article, we explore key regulatory standards, the importance of risk management, and how to overcome technical challenges in integrating electrical safety and software.
Download the Guide “Common Pitfalls for MDSW Regulatory Compliance”
For manufacturers, adhering to regulatory requirements is essential. Two key standards govern the safety and performance of medical devices: IEC 60601-series for electrical safety and IEC 62304 for software lifecycle processes.
IEC 60601 outlines the requirements for the electrical safety of medical devices, ensuring that devices are designed to protect users and patients from electrical hazards. It covers key areas such as power supply, electromagnetic compatibility, and protection against electric shock. The standard also includes requirements for programmable electrical medical systems (PEMS).
IEC 62304, meanwhile, focuses on the lifecycle management of medical device software. This standard ensures that software is developed and maintained using a risk-based approach, managing potential software failures that could affect device safety.
Together, these standards provide a framework for manufacturers to ensure their devices meet safety and performance criteria. Compliance with both IEC 60601 and IEC 62304 helps ensure that devices function reliably in real-world conditions, minimizing risks for both patients and healthcare providers.
Electrical safety and software risk management must be approached as an integrated process. Failing to account for how electrical malfunctions can affect software, or how software bugs can disrupt electrical functions, can lead to serious safety issues.
For example, an electrical fault such as a power surge could trigger a software malfunction, potentially rendering a device inoperable at a critical moment. On the other hand, software issues—such as a bug introduced in an update—could result in incorrect electrical outputs, leading to overheating or device failure.
By adopting an integrated risk management process, manufacturers can anticipate how risks in one area might impact the other. Risk assessments should cover both electrical and software-related hazards, and strategies for mitigating these risks must be implemented at every stage of development, from design through to post-market surveillance. A well-managed, holistic approach to risk ensures that devices remain safe and functional throughout their lifecycle.
The integration of electrical safety and software in medical devices presents several technical challenges, particularly as devices become more complex and interconnected.
Common issues include:
Solutions include:
With increasing connectivity in medical devices, cybersecurity has become an integral part of product safety. Many medical devices now communicate wirelessly, creating potential entry points for cyberattacks that could compromise both software and electrical safety.
For instance, a cybersecurity breach could allow malicious actors to tamper with a device’s electrical functions, posing direct risks to patients. To mitigate these risks, manufacturers must implement robust cybersecurity protocols, such as encryption and access controls, while ensuring that these security measures do not interfere with the device’s performance.
Incorporating cybersecurity strategies into the development process helps ensure that devices remain safe from both electrical malfunctions and data breaches. By viewing cybersecurity as an integral part of software and electrical safety, manufacturers can create devices that are safe, reliable, and secure.
The integration of electrical safety and software in medical devices is a complex but critical task. By adhering to regulatory standards and implementing a risk-based approach to design and testing, manufacturers can ensure that their devices meet the highest standards of safety and performance.
At GBA Key2Compliance, we offer expert guidance to help manufacturers navigate the regulatory landscape and integrate electrical safety with MDSW. Whether you’re developing a new device or updating an existing product, our team is here to help.
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