ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for medical devices, including software that is considered a medical device. While ISO 13485 certification is not mandatory for selling hospital software, it offers several important benefits for companies involved in the development and distribution of medical device software.
Incorporating ISO 13485:2016 and ISO 14971:2019 into SYNAPSIS™ development process required commitment and resources, but the benefits in terms of patient safety, regulatory compliance, and market acceptance are significantly outweigh the investment.
Implementing ISO 13485 in our company brought a range of benefits that encompass regulatory compliance, quality management, risk mitigation, and enhanced patient safety.
After months, here we can share a few benefits we already noticed:
👉 Quality Assurance, which is crucial for SYNAPSIS™ as it helps prevent defects, ensures consistency, and reduces the likelihood of software-related incidents that could harm patients or disrupt medical processes.
👉 Risk awareness in our management processes. This is very important in SYNAPSIS™ development, where the potential consequences of software errors can be critical. By implementing effective risk management practices with ISO 14971:2019 compliance, we can identify and mitigate potential hazards associated with our software.
👉 Implementing ISO 13485 required the establishment of efficient and well-documented processes. This can lead to streamlined development, testing, and deployment cycles, improving time-to-market for software updates and new features.
👉 Procesess provides a framework for demonstrating compliance with relevant regulations, such as the European Union’s Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA) regulations. It gives us peace of mind to focus on developing and conquering new markets.
Implementing certification not only supported regulatory alignment but also instilled confidence among our stakeholders: hospitals, healthcare providers, and our distributors by demonstrating a commitment to producing safe, high quality software.
We feel that this approach will foster continuous improvement, facilitate market access and position SYNAPSIS™ at the forefront of the industry.
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