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Developing SaMD in Conformance with ISO 13485

ISO 13485 provides valuable guidance to create effective quality management systems for your medical technology company while ensuring compliance with global regulations. Find out everything you need to know about this QMS standard and how you can use it to help your SaMD company.

If you’re working to develop medical technology or software you are likely familiar with ISO 13485. But a passing familiarity is simply not enough to use this process to your company’s full advantage. After all, this system outlines everything you need to build an effective and efficient QMS to bring your product to market while meeting all necessary safety requirements and regulatory steps.

But taking ISO 13485 and implementing it verbatim into your company’s flow regardless of what you are creating or who you’re creating it for is not how this tool is meant to be used.

Below, we’ll look at what ISO 13485 is, the benefits of using it to define your quality management system, and what challenges your company might face as they put this tool to use.

What Is ISO 13485?

ISO 13485 is a standalone quality management system (QMS) standard based on the ISO 9001 process. It features the same flow model of plan, do, check, act as previous ISO processes, but has been specially designed for implementation in the medical device industry. Specifically, it creates a prescriptive process to ensure regulatory compliance and the creation of safe and effective Software as a Medical Device (SaMD).

A QMS is a formalized framework of policies, documents, and procedures for achieving quality objectives. In the medical tech world, a QMS is vital for meeting regulatory guidelines and the needs of the patient or end user. ISO 13485 exists to help medical technology companies quickly and effectively deploy their own QMS that will work within the framework of their company while still meeting all external requirements and ensuring a safe and usable final product.

The Benefits of Using ISO 13485 to Develop QMS

While this QMS standard exists as a concrete, defined process, it is meant to be adjusted and refined to maximize efficiency. This is where most companies fail to use ISO 13485 to their full advantage. While this process is highly prescriptive in nature, it does not provide every piece of information needed to create a perfect QMS for every individual company. 

Instead, it provides a framework that will help you hit all vital elements of a QMS within the medical device industry. These elements include:

  • Processes for identifying and eliminating mistakes
  • A framework that assures all regulatory requirements are met
  • Role definement for increased employee involvement and productivity
  • Data feedback for evidence-based decision making
  • Processes for identifying waste in time and resources to create more efficient QMS
  • Implementation of marketing requirements with processes to meet these goals
  • Thorough testing processes to improve product safety
  • Delivery of quality products to build increased customer satisfaction

The key to using ISO 13485 to create sleek, efficient QMS within your company is to adopt these elements in a way that fits with your culture, company setup, and end goals. If you don’t do this, then you end up with a rigid, rules-based QMS that only serves to restrict movement and growth, leading to inefficiencies and waste.

The Challenges of Implementing ISO 13485 QMS

Finding the balance between using ISO 13485 as a rigid framework that fails to incorporate your company’s needs and taking too many liberties with the standard to create a safe product is a tough challenge for companies to take on alone. This is especially true for device companies that are used to working with hardware.

Creating QMS for hardware is a different process than creating QMS for software. Hardware requires a waterfall approach with meticulous care put to each consecutive step. Software, on the other hand, is far more malleable, allowing for the overlapping of processes and a more agile approach to QMS.

When applying ISO 13485 to SaMD you not only need to find a way to fit the framework to your company, but you must also align the processes to the needs of the hardware and software simultaneously. If you don’t have experience working with software quality management systems, then this is going to be a difficult task.

Partnering with a knowledgeable software development company that is also ISO 13485 compliant, like Sequenex, ensures your SaMD will be developed following optimized medical technology QMS while meeting all regulatory steps and fully utilizing the safety and efficiency processes set forth by ISO 13485.

If you’re struggling to align your company’s existing QMS with ISO 13485 or don’t believe you’re taking full advantage of the framework presented within it, we can help. Contact us today to find out how our services were created for innovative diabetes technology device companies just like yours.

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