Innowise becomes an ISO 13485 certified company: what it means for our clients

Feb 13, 2025 4 min read

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Starting 2025 strong, Innowise receives an ISO 13485 certification — proof of compliance with a world-renowned framework that regulates the manufacturing of medical devices as well as the development of medical device software and SaMD.

This certification is a testament to the maturity of our quality management approach, the development practices we use, and the overall dedication of Innowise’s team to deliver the best software for the healthcare and life sciences fields. In this article, we’ll walk you through what it means for Innowise and our healthcare clients.

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What is ISO 13485

ISO 13485 is a standard that regulates the process of design and manufacturing of medical devices, granted by the International Standardization Organization. The standard sets out rules for the quality management practices that help guarantee that the products are safe and efficient. It also covers the development of:

SaMD (software as a medical device), is the software that is used to perform disease diagnostics, management, or treatment without being a part of a physical medical device. Examples: clinical decision support apps, tumor detection software, or sleep apnea identification apps.
SiMD (software in a medical device), is the software that is an integral part of a medical device and either controls its performance or ensures specific medical functions. Examples: embedded pacemaker software, insulin dosage calculation algorithms within glucometers, and AI algorithms for medical image analysis.

What it means for our clients

If you work in the healthcare or life sciences sectors, you know that finding an IT vendor who is actually good at the job may be particularly challenging. ISO certifications provide a sort of a shortcut: you can just check if the vendor has a relevant acknowledgment, and be sure of the quality of services it provides. Here is what ISO 13485 stands for us at Innowise.

Compliance

Whether you already work with Innowise or only consider our company as a partner for your healthcare IT projects, you can be certain that we follow all guidelines for medical device software development stated in ISO 13485. Besides, as ISO 13485 is harmonized with IEC 62304 and IEC 82304-1, it means we comply with these standards for health and medical device software by default.

Quality

We are well-equipped to deliver SaMD and SiMD and have top-tier risk management, compliance, and operational efficiency practices in place. Also, Innowise already has ISO 9001 and ISO 27001 certifications that back our quality and security management practices. The ISO 13485 certification we recently obtained is a solid addition to our portfolio of industry recognitions.

Innovation

Our team and I believe that it is just the beginning — the certification opens up new horizons for us and our clients. We are looking forward to developing more advanced SaMD solutions, leveraging the potential of technologies like AI, ML, and big data to the fullest.

“Becoming an ISO 13485 certified company is truly a milestone for Innowise. We are proud that the years of meticulous work we’ve put into perfecting our processes are recognized by the leading standardization authority. We are open to even more innovative projects for healthcare and life sciences, and I’m excited to see what’s next for us.”

Dmitry Nazarevich

Chief Technology Officer

Projects that helped us hone our healthcare IT expertise

ISO 13485 certified supplier to turn your ideas into reality

Over the years, Innowise has been a dependable partner to hundreds of clients and completed 60+ successful healthcare projects. Our solutions already empower thousands of healthcare professionals to make informed care decisions, correctly diagnose patients, monitor disease progression, and more.

Receiving ISO 13485 certification is a natural step for Innowise, considering our extensive experience with embedded software, IoT, and robotics. Now, we are ready to take on a broader spectrum of healthcare IT projects, including SaMD and SiMD solutions. If you are looking for a technology partner, just drop us a line and our healthcare IT experts will help you plan and build the solution you need.

Aleh Yafimau

Healthcare IT Consultant

Aleh bridges the gap between clinical needs and engineering execution. He applies deep domain knowledge to ensure MedTech systems are not just compliant, but reliable enough to make a measurable impact in real-world healthcare.

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