IEC 62304 - An Introduction

IEC 62304 is an international standard that specifies requirements for the life cycle processes of medical device software. It guides the development, maintenance, and risk management of software used in medical devices.

The standard applies to the entire software life cycle, including software development, verification, validation, and maintenance processes. It covers software used in medical devices, including embedded software, firmware, and software that is part of a medical device / standalone software (SAMd).

The IEC 62304 standard establishes a cohesive framework for designing and testing software for medical devices through defined processes, activities, and tasks, ensuring safe usage in patients. The standard categorizes software into three safety classes according to the risk to the patient from a possible software failure

• Class A: No injury or damage to health is possible
• Class B: Non-serious injury is possible
• Class C: Death or serious injury is possible

The subsequent 5 chapters of IEC 62304 detail specific requirements and guidelines for the development and proper implementation of medical device software

• Chapter 5: Software development and planning process including requirements analysis, design, testing, and release processes
• Chapter 6: Software maintenance plan, including the implementation of a maintenance plan and issue analysis procedures
• Chapter 7: Software risk management and Identification of hazardous situations, risk control, verification, and risk management procedures following the ISO 14971 standard
• Chapter 8: Software configuration management including change control and configuration status tracking
• Chapter 9: Software problem resolution investigating and reporting on problems, change control processes, trend analysis, and resolution testing and verification

The FDA encourages the use of recognized consensus standards to show compliance. IEC 62304 is a standard acknowledged by the FDA for this purpose. Employing IEC 62304 can facilitate the 510(k) submission process as it offers a comprehensive framework for software development, risk management, and documentation.

IEC 62304 consultants play a vital role in guiding organizations through the process of complying with the standard’s requirements and implementing best practices for medical device standard compliance. Here’s a breakdown of their key roles:

• Consultants bring in-depth knowledge of the IEC 62304 standard and its application to medical device software. They provide expert guidance on interpreting the requirements, identifying relevant processes, drafting mandatory procedures based on software risk class and drafting record templates to achieve compliance.
• Integration of the IEC 62304 process to your medical device quality management system (ISO 13485) and or 21 CFR 820 or FDA QMSR.
• Internal Audit support
• Onsite Audit support

In general, IEC 62304 consultants play a crucial role in helping organizations navigate the complexities of medical device software regulatory compliance

Implementing the IEC 62304 standard offers several benefits for software medical device manufacturers (SAMD & SIMD). A few are listed below:

• Compliance with IEC 62304 helps ensure that medical device software is developed with patient safety as a primary consideration. By identifying and mitigating risks throughout the software lifecycle, organizations can minimize the likelihood of software-related errors or malfunctions that could harm patients

• Adhering to IEC 62304 facilitates compliance with regulatory requirements in the European Union, the United States, and other regions where the standard is recognized. This can streamline the regulatory approval process and expedite certifications and approvals faster

• The standard emphasizes the importance of risk management in medical software. By systematically identifying, assessing, and mitigating risks, organizations can proactively address potential hazards and ensure the safety and effectiveness of their final released software

IEC 62304 is a standard that outlines requirements and guidelines for the development of medical device software; however, it does not ask for a certification or no certification body issues certificates. Organizations can demonstrate compliance with IEC 62304 by implementing the standard’s requirements and following its guidelines throughout their software development processes

While there is no formal certification for IEC 62304 compliance, organizations can still provide evidence of their adherence to the standard through documentation and audit reports. This can help build confidence in customers, regulatory authorities, and other stakeholders

Compliance with IEC 62304 is a mandatory requirement for US FDA during 510k submission and the European Union’s Notified Bodies, as part of EU MDR CE Marking and IVDR technical documentation file submission.

Developing procedures compliant with IEC 62304 requires a systematic approach to software development, verification, validation, and maintenance.  These procedures should be prepared to the specific needs and context of your organization and should be documented, implemented, and maintained based on a medical device quality management system platform such as ISO 13485 OR 21 CFR 820 or FDA QMSR.

Here’s a general outline of procedures you might consider implementing: