Develop medical device software centred on patients and compliant with ISO 13485, IEC 62304 and MDR

Medical domains we specialise in

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E-therapy management

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Diagnostic & monitoring systems

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Connected health solutions & telemonitoring

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Disease treatments

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Clinical trial solutions

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Adherence management

Get help with EU MDR compliance

Have us conduct an independent audit and review the documentation of your medical device against the provisions of the EU MDR regulation that introduced the concept of software as a medical device.

By combining our expertise with your deep understanding of the product, we can identify key issues and come up with the most beneficial solution.

Learn more about the changes introduced in the Medical Device Regulation.

Certifications & compliance

DAS-Ukas-ISO-27001
ISO-13485-2016
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IEC_62304
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What we do

You can trust us in delivering a complete medical solution following all safety standards

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Medical Devices & Medical Equipment

  1. Software for laboratory and rehabilitation equipment, patient monitoring products and automated drug delivery systems.
  2. Machine control systems for monitoring the operating status of equipment or using a sensor fusion technology to combine data from different medical devices.
  3. Secure and real-time operating systems that can be updated on the spot and connected with the cloud ecosystem.
  4. Software for analysing and processing data from medical devices.
  5. Electronic hardware and design Human-Machine Interfaces (HMI).
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Medical enterprise systems

  1. Enterprise systems, ranging from medical facility management, through patient and treatment management, to rehabilitation applications.
  2. Machine to Machine solutions that enable data exchange between medical devices and their integration.
  3. Systems for predicting the operation of medical equipment and its remote diagnostics, as well as for managing equipment and spare parts.
  4. Cloud migration for scale processing of large amounts of medical data.
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Medical devices connectivity

Communication solutions for medical devices using:

  • wireless modules (2G-5G),
  • WiFi,
  • Bluetooth,
  • RFID
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Medical algorithms

Implementing medical algorithms to ensure a high level of:

  • movement correctness for rehabilitation solutions,
  • image recognition for medical imaging,
  • sound quality and diagnostic processes in measurement analysis
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Krzysztof Minnicki

ABOUT ME

Working for the Medtech sector allows me to continuously challenge myself

Krzysztof Minicki
DIRECTOR OF HEALTHCARE & LIFE SCIENCES

I’ve been developing software for as long as I can remember. I started as a developer and migrated through many different roles in various IT projects. The knowledge and experience I gained allowed me to achieve a comprehensive understanding of the software development process and tailor it to clients’ needs. I’ve been using this skill for the past few years, i.e. when building medical products. I know how to swiftly and effectively develop software addressing all current regulations that’s both safe for patients and will provide them with tangible benefits.

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CONTACT

Interested in collaborating with me?
Get in touch.
Krzysztof Minicki
DIRECTOR OF HEALTHCARE & LIFE SCIENCES





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