Make certain that your medical software meets all the EU MDR requirements

Spyrosoft ikonkiai_1.-Have your product smoothly aligned with the MDR requirements

Have your product smoothly aligned with the MDR requirements

Have an EU MDR compliance plan set up and carried out by our experts to avoid any obstacles in the process.

Spyrosoft ikonkiai_2.-Ensure that your medical software is properly classified

Ensure that your medical software is properly classified

Have us analyse your software’s Intended Use and determine whether it qualifies as a medical device and what class it falls under.

Spyrosoft ikonkiai_3.-Get a ready-to-use Technical File

Get a ready-to-use Technical File

Have us adjust or prepare MDR-compliant Technical File for your product.

Spyrosoft ikonkiai_4.-Optimize the development costs

Optimize the development costs

We can help you decompose your complex system on the software architecture level into modules that belong to lower software classes to drive down development costs.

Spyrosoft ikonkiai_5.-Get your team trained in the EU MDR

Get your team trained in the EU MDR

Learn the best practices and tools for smooth implementation of the EU MDR principles.

"Our consultants have extensive experience in the medical device industry. As a company, we also have been preparing for the MDR for a very long time, both in terms of extending our own knowledge and adapting our quality systems to comply with the new regulation."

Krzysztof Minicki, Director of Healthcare and Life Sciences

Krzysztof_Minicki_www_trojkat

How we can help you apply the EU MDR requirements

Spyrosoft ikonkiai_6.- Consultations

Consultations

  • Independent audit with a gap analysis

We check to what extent your product meets the requirements by reviewing the documentation of your medical device against the provisions of the EU MDR regulation.

  • Finding optimal solutions

Based on the audit results, we prepare a report of issues that need to be addressed. Then, by combining your deep understanding of the product with our expertise, together we work out the optimal solution - the most beneficial and convenient for you in terms of implementation.

Spyrosoft ikonkiai_7.-Assistance in medical device classification

Assistance in medical device classification

We’ll help you determine the class of your new or already existing software according to the revised classification criteria introduced by the EU MDR.  

Spyrosoft ikonkiai_8.-Training sessions and workshops

Training sessions and workshops

We’ll guide you through the theory and practical application of selected MDR issues, such as the approach to classification of medical devices under the MDR, or the consequences of switching from the MDD to MDR. 

Spyrosoft ikonkiai_9.-Advice on conducting post-market activities

Advice on conducting post-market activities

We’ll suggest to you good practices and solutions for activities, such as monitoring and reporting, that the EU MDR requires to be conducted for software qualified as a medical device that is already on the market.  

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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 us

Get your software MDR-compliant with expert help
Krzysztof Minicki
DIRECTOR OF HEALTHCARE & LIFE SCIENCES





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