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

Aleh Yafimau, Healthcare and MedTech Delivery Manager..
Healthcare IT Consultant
Verified expert
Every article at Innowise is created by authors with real-world experience. They understand the topic beyond theory and bring insight from real projects.
19+ years of experience
Verified expert
19+ years of experience
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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Healthcare IT Medtech Algorithms
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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.

Looking for an ISO 13485 certified partner?

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, CTO.
Dmitry Nazarevich
Chief Technology Officer

Projects that helped us hone our healthcare IT expertise

Privacy-preserving breast cancer detection with federated learning
Innowise implemented a federated learning framework that enabled 3 clinics to collaboratively train a breast cancer detection model.
<68.6% improvement in segmentation AP
10,500 mammography images in an imaging repository
iOS and VR meditation app suite for Grožio Planeta UAB
We built a set of meditation apps for Grožio Planeta UAB, helping users practice guided sessions on iOS and in VR.
100 in-app guided meditations
7 languages supported
View case study
Client review
View case study
Client review logo. Client review
iOS and VR meditation app suite for Grožio Planeta UAB..
Designing a data integration gateway for FIM Medical
Innowise upgraded the client’s proprietary desktop app with an FHIR-based integration gateway to connect their diagnostic software with EHR systems.
3 months to complete all integrations
RFID tag data decoding module for Telea Medical
Innowise completely overhauled the RFID tag data decoding module for Telea Medical, an EU-based medical device manufacturer.
4 weeks for a full module rewrite
100% accurate RFID data processing
View case study
Client review
View case study
Client review logo. Client review
RFID tag data decoding module for Telea Medical.
Gym membership app support & improvement
We helped upgrade the client’s gym membership management app, contributing to growing customer satisfaction, brand loyalty, and user retention.
Upgrade of a radiation exposure monitoring app
Innowise upgraded a radiation exposure monitoring app, improving the response time and laying the groundwork for the software functionality scale-up.
Monolithic to microservices migration
Innowise successfully migrated the client’s platform from a monolithic architecture to microservices, boosting scalability and performance.
AI dermatologist skin scanner app
An AI app we built uses deep learning and image recognition to quickly assess skin conditions, giving preliminary diagnoses based on photos.
30 dermatological conditions supported
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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.

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