The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software. This standard is orchestrated by the European Union and the United States and can be used as a key benchmark for compliance within both of these markets.

IEC 62304 is a critical safety certification that ensures that your product works as intended and is safe for general use. Unfortunately, without proper verification preparation, you can be blindsided by unforeseen requirements.

With that in mind, let's take a look at five major compliance mistakes organizations make so you can learn how to avoid enduring a similar fate.

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

Medical software companies need to follow a proven and systematized process to streamline the entire verification process. Beyond that, they also need to avoid the major mistakes that manufacturers make during the software development process.

Here are the five major IEC 62304 compliance mistakes that many medical software manufacturers make during the verification process.

1. Failure to Implement Solid Design Control Process

Many medical software manufacturers fail to build solid design control processes and change management protocols.

Change control is essential to keep a full record of your documents and products. Theoretically, change control is feasible with a paper-based quality management system. But for more complex process changes, an electronic system can simplify the entire design and change control process.

There are always documents associated with any system—whether it's an equipment file containing the manual and validation or a simple SOP change. An electronic quality management system (eQMS) makes it all visible to the required parties in real-time. 

RELATED: What is a Document Control System and Why Does it Matter?

2. Failure to Align Documentation with IEC 62304 Semantics

Unfortunately, failure to ensure that documentation aligns with the semantics of the standard, including IEC 62304 and FDA guidance, is another major misstep that medical software companies make all too often during the verification process.

To ensure compliance, documents need to move in a predictable and traceable way through your company from one department to the next. Every move must be well-documented.

To avoid making a similar mistake, we recommend referring to guiding documentation. This guidance document outlines the recommended documentation you should include in premarket submissions.

3. Failure to Understand Post-Market Surveillance

Some medical software developers simply don't understand what post-market surveillance means, nor do they have the process in place to gather that information and create significant product improvements.

This is different from usual SaaS customer feedback, which requires you to always assess feedback through the lens of customer/patient and then implement pertinent change controls to take you all the way back through the design process if necessary.

RELATED: 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations

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4. Failure to Identify Solid Software Development Process

Building and managing a software development process is a massive undertaking that many software developers struggle with.

Software as-a-medical device (SaMD) is regulated like any other medical device. But the process isn't the same for medical device manufacturers creating software applications. At best, if you don't manage these requirements effectively, you'll slow the time to market. At worst, there are significant liability concerns that may result in steep penalties or fines.

The right eQMS integration can make it a lot easier to meet unique requirements for managing quality processes while developing SaMD solutions.

5. Failure to Identify Problem Tracking and Mitigation Response

When unforeseen issues arise in the software development process, your organization must have a framework in place to appropriately track and mitigate the issue rapidly. Moreover, software problem resolution needs to be well-documented.

IEC 62304 safety standards describe the process for software problem resolution across the following areas:

  • Prepare problem reports
  • Investigate the problem
  • Advise internal parties
  • Use change control process
  • Maintain records
  • Analyze problems for trends
  • Verify software problem resolution
  • Test documentation contents

Invest in Quality Management to Ensure Medical Software Success

The right quality management software can offer a diverse range of benefits in the medical software development process.

Successfully shifting to a quality-driven culture requires full support from leadership teams and a commitment to change. The right quality management system should fit seamlessly into your organization's existing framework.

To achieve the financial and collaborative benefits possible with an eQMS and deliver seamless IEC 62304 verification, make sure your eQMS selection is well-researched.

We recommend downloading this free guide: 12 Questions to Ask Before You Buy an eQMS. Take a look to learn more about the questions you need to ask vendors as you evaluate your eQMS options.

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Published by Robert Fenton October 13, 2020
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