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.
Develop medical device software centred on patients and compliant with ISO 13485, IEC 62304 and MDR
WHAT WE DO
from product concept to maintenance.
Take advantage of our ready-to-use quality management system:
● designed for seamless ISO 13485 and GMP/FDA audits,
● with a full set of standard operating procedures for your medical device development and submission needs,
● including workflows to ensure compliance with the latest medical regulations at all phases of your device lifecycle.
Get trained in ISO 13485, ISO 14971 Medical Device Risk Management, IEC 62304 Medical Device Software life cycle processes, Verification and Validation of Medical Devices.
Implement, adapt or improve the QMS ISO 13485 and a certification process in your organisation with support from our specialists.
Make your product development process successful right from the start:
● conceptualise your product or product vision through workshops with our experts,
● get support with establishing Regulatory Strategy, Medical Device classification and Software classification documents,
● ensure your Medical Device Risk management is performed according to ISO 14971 Medical Device Risk Management,
● have software architects draw initial solution architecture,
● get assistance in planning and tailoring Medical Device Software life cycle processes according to IEC 62304 and your needs,
● implement a Proof of Concept, that will allow you to quickly check your business constraints or any technological aspects,
● have a Clinical Trial performed on your ready-to-use solution.
Have your product designed and developed according to Agile Development Lifecycle and in compliance with IEC 62304.
● Strategy:regulatory requirements, POC, initial architecture
● Pre-development: intended use definition, medical device & software classification, compliance strategy
● Quality management: support and/or creation of quality management system in line with ISO 13485
● R&D process: effective process adaptation and adjustment
● Clinical trial: support and solution delivery
● Software risk assessment: compliance check with ISO 14971
Ensure your submission or certification process goes without a hitch.
We’ll support you in:
● reviewing your submission/certification documentation including the Technical File,
● creating Submission Readiness Report with highlighted GAPs,
● resolving issues found,
● preparing submission or certification documentation, CE Marking, 510K.
Meet EU MDR requirements with our help in:
● medical device re-classification,
● Technical File adjustment and preparation,
● identifying and resolving any obstacles in the submission process.
Your solution will be:
● monitored in real time,
● auto-scalable because it’s based on the cloud/AI,
● designed with high usability guaranteed by ISO 62366 compliance,
● safe by design and compliant with IEC 62304 and ISO 27001.
You can also have us handle the post-market activities, such as:
● product maintenance,
● L1 – L3 support lines,
● data collection and analysis,
● post-market Activities Management System and reporting,
● constant improvements and adaptation to changing requirements.
Medical domains we specialise in

E-therapy management

Diagnostic & monitoring systems

Connected health solutions & telemonitoring

Disease treatments

Clinical trial solutions

Adherence management
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Patient’s digital engagement
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Cloud, Big Data and AI
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Medical treatment and monitoring
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Post-market activities management and payer systems
● wearable medical devices,
● Connectivity,
● embedded solutions and microcontrollers,
● UX/UI design,
● mobile, web, smartwatch apps development.
● electronic health records (using image recognition, OCR, ML search engine),
● patient show and no-show prediction,
● clinical decision support systems,
● wearable analytics for anomaly detection, pattern extraction,
● transition to the cloud as well as provisioning and maintenance of the cloud infrastructure,
● automating software delivery and deployment pipeline.
● medical algorithms,
● clinical decision support systems,
● patient monitoring and alerting systems,
● product design,
● UI/UX user interface design,
● embedded, mobile apps, web software development.
● payer algorithms and reporting,
● system integration,
● complaint management systems,
● adverse events management systems,
● prediction and trending monitoring (using AI).





Get help with EU MDR compliance
Certifications & compliance






Our services
You can trust us in delivering a complete medical solution following all safety standards
Medical Devices & Medical Equipment
- Software for laboratory and rehabilitation equipment, patient monitoring products and automated drug delivery systems.
- Machine control systems for monitoring the operating status of equipment or using a sensor fusion technology to combine data from different medical devices.
- Secure and real-time operating systems that can be updated on the spot and connected with the cloud ecosystem.
- Software for analysing and processing data from medical devices.
- Electronic hardware and design Human-Machine Interfaces (HMI).
Medical enterprise systems
- Enterprise systems, ranging from medical facility management, through patient and treatment management, to rehabilitation applications.
- Machine to Machine solutions that enable data exchange between medical devices and their integration.
- Systems for predicting the operation of medical equipment and its remote diagnostics, as well as for managing equipment and spare parts.
- Cloud migration for scale processing of large amounts of medical data.
Medical devices connectivity
Communication solutions for medical devices using:
- wireless modules (2G-5G),
- WiFi,
- Bluetooth,
- RFID
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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ABOUT ME
Working for the Medtech sector allows me to continuously challenge myself
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.
CONTACT
Get in touch.


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