Medical & Diagnostics Devices

SECTOR-FOCUSED SOLUTIONS

Software Development

Software for Medical and Diagnostic Devices

We develop solutions that ensure your medical and diagnostic devices operate safely and reliably while meeting all industry requirements. The software we create enhances device functionality, ensures regulatory compliance, and helps build long-term trust in your product.

Development of embedded software and firmware (IEC 62304, SiMD)
Integration of usability and risk management (IEC 62366, ISO 14971)
Development of dedicated software in C/C++, “bare metal,” Linux Yocto, and RTOS
Software compliant with IoT, IoMT, DTx (Digital Therapeutics) standards, and cloud solutions

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Firmware and embedded software R&D

Hardware Development

Maximum performance through standards compliance

We design and develop equipment that meets rigorous standards, ensuring durability, efficiency, and reliability at the same time. From concept to production, we create devices with the goal of delivering top performance in real-world conditions.

Full-Product Engineering services – Concept Design, 3D CAD modeling, and mechanical/electrical/optical design
PCB and schematic design in compliance with IEC 60601
FEM simulation, prototyping, and hardware configuration
Testing in secure laboratories
Documentation preparation

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Hardware services

Product Design Studio

Embedded Testing

Reliable and accurate hardware performance

We offer built-in testing solutions that ensure the performance, consistency, and safety of devices while minimizing the risk of failure. We make sure they are fully ready for use by patients.

Verification of compliance with standards (ISO 13485, IEC 62304, IEC 60601, IEC 62366)
Integration with Quality Management Systems (QMS) and documentation
Vulnerability, threat, and cybersecurity analysis
Test automation
Comprehensive quality testing (system, penetration, modular, integration, unit) – 100% code coverage in unit tests
HIL testing (simulators, emulators, middleware)

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GxP Compliance

Embedded testing

Security & Compliance

Cybersecurity of Medical Software and Devices

We offer comprehensive protection of cloud, data, and infrastructure, as well as monitoring services. We provide services in the field of security and compliance with medical industry standards (Medical Compliance) – for both SiMD and SaMD. We are certified according to ISO 13485.

Implementation and maintenance of compliance standards with GDPR, ISO, NIS2
Cybersecurity for medical devices (SiMD/SaMD)
Ensuring compliance with requirements (MDR 2017/745, IVDR 2017/746, FDA 510(k), ISO 13485, ISO 14971, IEC 62304)
Consulting in risk management (ISO 14971) and usability engineering (IEC 62366)
Support in documentation and QMS, Design Control processes
Ensuring compliance in sales, support, and documentation audits

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Security of Medical Devices

Embedded Cybersecurity

AI & Bioinformatics

AI for drug development, R&D, and simulation

We use advanced artificial intelligence and bioinformatics to analyze complex biological data. Our solutions enable faster, data-driven research decisions, supporting drug discovery, therapy development, and personalized medicine.

Data Science & Data Engineering
Generative AI (LLM, RAG), Medical Text Processing (NLP)
Image recognition and computer vision
Support for research into drug discovery and therapy
AI tools

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Generative AI

Microsoft Copilot

OUR ONE-STOP-SHOP SERVICES

INDUSTRY LEADERS TRUSTED US

case studies

A new online platform to support the international expansion of Blatchford

Explore how Sii enhanced the international expansion of a leading prosthetic technology manufacturer through a modern, SEO- and mobile-friendly website with the best industry standards. The efficient and scalable solution hosted on Azure cloud, easy adaptation to business changes, and simple content and product management for various markets allowed smooth access to new clients worldwide.

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A new online platform to support the international expansion of Blatchford

Support for AI software development in infertility

Mojo Fertility is a start-up that has developed an AI-based solution to increase the success rate of infertility treatment from 25% to 75%. Check out how our services improved the software quality of the client's revolutionary solution and allowed it to expand its business with new semen sample processing centers.

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Support for AI software development in infertility

DNA analysis using dPCR for Qiagen

Discover how the dPCR DNA analysis software we developed enabled the processing of images sent directly from a customer's device. Qiagen, a leader in providing molecular testing solutions, received a tool with key features needed to grow the company, including absolute quantification, mutation detection, genome editing, copy number alteration, and gene expression analysis.

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A new online platform to support the international expansion of Blatchford

Support for AI software development in infertility

DNA analysis using dPCR for Qiagen

See all case studies

meet our experts

Wojciech Drescher

Head of Healthcare

Wojciech has supported sales processes at Sii Polska since 2013 and currently holds the position of Head of Industry Healthcare. He is fascinated with the areas of Digital Therapeutics and Bioinformatics, improving and empowering human health & well-being. Wojciech has established cooperation with dozens of international clients from healthcare & life science customers, bringing new quality to the projects from the sector.

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Marek Matuszak

Medical Equipment SW/HW Architect

An expert in R&D with over 11 years of experience. He specializes in managing projects related to medical hardware, software, and HV components, as well as RFID technology and team leadership. His expertise is confirmed by successfully ensuring compliance with safety standards IEC 60601 and IEC 62304, Class C, and submitting FDA 510(k) applications.

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Natalia Grzelak-Żok

Senior Security Consultant

For nine years, she has been involved in the medical industry. She specializes in preparing documentation and performing risk analyses for medical devices and software, ensuring full alignment with regulatory requirements. At Sii, she also supports clients in the area of medical device cybersecurity by developing the technical documentation required for 510(k) submissions. Privately, she is passionate about sports and an active lifestyle, and she enjoys spending her free time outdoors, training with her dog.

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Krzysztof Cygoń

Senior Security Consultant

A biomedical engineer with over 10 years of experience in the industry. Krzysztof pecializes in product development and implementation, product lifecycle management, and ensuring compliance with quality standards (ISO 9001, ISO 13485). She has experience in conducting research in both medical and sports fields, as well as in delivering presentations and public speaking. In his work, she values effective organization and collaboration—both as a team leader and team member. His management philosophy is based on the principle: "there is no 'I' in team." Privately, he appreciates new challenges and eagerly takes on ambitious projects.

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Michał Klimont

Consultant

Interventional and diagnostic radiologist with a strong academic and clinical background in neuroradiology and AI-based image analysis. Michał holds a European Diploma in Radiology and completed a PhD focused on machine learning methods for radiological image processing. He has worked internationally in both clinical and R&D roles, including at a leading US-based medical software and hardware company and Stanford AIMI, contributing to the development of AI tools for neuroimaging. At Sii, he leverages his combined expertise in radiology and data science to support innovation in medical imaging technologies.

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CHECK OUT OUR STORIES

See how we support our clients in the medical industry

EVENTS & INSIGHTS

Medical compliance: What you must know before market launch

Sii Poland contributes to enhancing the quality of life in ostomy care

Sii Poland named Tricentis Alps CEE Partner of the Year 2025: Milestone in Software Quality Assurance

Medical compliance: What you must know before market launch

Sii Poland contributes to enhancing the quality of life in ostomy care

Sii Poland named Tricentis Alps CEE Partner of the Year 2025: Milestone in Software Quality Assurance

GET IN TOUCH

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Wojciech Drescher

Head of Industry

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Offices in Poland

Sii Sweden

Sii Ukraine

Sii India

Automating financial analysis with AI

Berlingske Media enters the digital-first era – platform modernization with Sii Poland

Quality Control Center for ABB – gaining control over IT system quality

E-commerce modernization to support growth and smooth shopping experience

Cyber Resilience Act Demystified: Risks, Regulations, and the DevSecOps Approach

Microsoft Dynamics 365 Contact Center: how Sii helps organizations build modern, AI-powered customer service

How Agentic AI is transforming system integration in modern organizations

Identity Security in practice: Sii Poland joins SailPoint's partner network

Multi‑Agent AI for Embedded Software Development

Take control over your cloud costs with FinOps

DevSecOps Done Right: Embedding Security Without Sacrifices

Leveraging AI and Playwright for efficient UI & API testing

What does the code from Sii Testing Lab look like? Repositories deep-dive

How to set up branch policies in Azure DevOps: Complete guide for PR validation

From automation to autonomy: The evolution towards Agentic Testing, illustrated by mabl

Practical application of AI models in programming. A comparison of GPT-5.4 and Claude Opus 4.7

Medical & Diagnostics Devices

Software for Medical and Diagnostic Devices

Maximum performance through standards compliance

Reliable and accurate hardware performance

Cybersecurity of Medical Software and Devices

AI for drug development, R&D, and simulation

A new online platform to support the international expansion of Blatchford

Support for AI software development in infertility

DNA analysis using dPCR for Qiagen

„Paperless” approach

NIS 2 Offering

Automation of packaging processes

Power Apps Customer Portal

EEG Visualizer project

Medical compliance: What you must know before market launch

Sii Poland contributes to enhancing the quality of life in ostomy care

Sii Poland named Tricentis Alps CEE Partner of the Year 2025: Milestone in Software Quality Assurance

Medical compliance: What you must know before market launch

Sii Poland contributes to enhancing the quality of life in ostomy care

Sii Poland named Tricentis Alps CEE Partner of the Year 2025: Milestone in Software Quality Assurance

Wojciech Drescher

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What we do

Industries

Who we are

Career

Trainings

News

Contact

Einige Inhalte sind nicht in deutscher Sprache verfügbar.
Sie werden zur englischen Version der ausgewählten Seite weitergeleitet.

Einige Inhalte sind nicht in deutscher Sprache verfügbar.
Sie werden auf die deutsche Homepage weitergeleitet.

Ta treść jest dostępna tylko w jednej wersji językowej.
Nastąpi przekierowanie do strony głównej.