What Are Standards?
All traditional medical devices are tested against standards. Standards are documents issued by an issuing agency that is typically a non-government entity. A standard will define a broad test methodology and acceptance criteria. Government regulators will adopt standards instead of developing their own country-specific requirements, which allows for global regulatory harmonization. By using standards, regulators are able to compare the performance of similar products more effectively.
The goal of a standard is to provide a standardized way to evaluate a device type, performance, or safety. This creates an unbiased way for the industry to study the device and harmonized methods for regulators to assess performance. As a medical device goes through life cycle iterations, manufacturers are responsible for assessing the impact of the change to existing standard testing and repeat standard testing to confirm performance and safety.
What is the Role of Standards in Medical Software?
When it comes to medical software, regulators have struggled with a harmonized approach to evaluate the software. The industry has struggled with developing a consistent method for conducting repeating safety and performance testing for software upgrades. Software tends to iterate far more rapidly than traditional medical devices. But not all software changes are significant; some improve bugs, user interface, design, or compatibility with operating systems.
To address these concerns for industry and regulators, the International Electrotechnical Commission (IEC) published “IEC 62304 Medical device software — Software life cycle processes.” This standard has been fully adopted by the FDA and European Commission, meaning all US and EU medical device software must comply with the requirements of this standard. IEC 62304 is a rapidly evolving standard and is currently being revised by the organization.
IEC 62304 is a functional safety standard that provides manufacturers with guidance on how to evaluate software throughout the device’s lifetime using their quality system. IEC 62304 provides manufacturers with specific guidance on how to develop, maintain, evaluate, and resolve issues with medical software. IEC 62304 breaks software down into three safety classes, and the requirements for software depends on the safety classification (i.e., a class A software may have less requirements when compared to a class C software).
- Class A: No injury or damage to health is possible.
- Class B: Injury is possible, but not serious.
- Class C: Death or serious injury is possible.
Guidance on Implementing IEC 62304
Manufacturers who are planning on implementing IEC 62304 into their organization will want to start by evaluating their quality system and documentation practices. Because of the rapid nature of software revisions, manufacturers will need to rely on an efficient and comprehensive quality system heavily. Once manufacturers have a software-compliant quality management system, then they are ready to begin evaluating and marketing their medical software.
If your organization is looking to implement IEC 62304, DeviceLab can help you ensure you have the appropriate tools to meet IEC 62304. Regardless of where you are in your medical software development, DeviceLab is here to help you. Our team has the experience and knowledge to implement IEC 62304. Contact us today to schedule your personal free and confidential consultation.