ABOUT THE MEDICAL DEVICE REGULATION
What are the changes brought about by the EU MDR?
The EU MDR aims at improving medical device safety for patients and other end users. To achieve that goal, it introduced new, stricter requirements for the manufacturers of medical devices released to the EU market, including software, both new and already existing. This resulted in lengthening the software development process as additional steps must be taken. The transition period to become EU MDR compliant for manufacturers of existing devices is four years, but only until any change to the product is implemented, also a software update. Therefore, it’s better to take steps to achieve MDR compliance as soon as possible.
Make sure that your medical software meets all the EU 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.
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.
Get a ready-to-use Technical File
Have us adjust or prepare an MDR-compliant Technical File for your product.
Optimise 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.
Get your team trained in the EU MDR
Learn the best practices and tools for the smooth implementation of the EU MDR principles.
MDR medical device checker
Are you unsure whether your product meets the requirements for being a medical device in compliance with MDR regulations in the EU?
Use our tool to assess whether your product is a medical device regarding MDR regulations and whether you should take appropriate steps to obtain the required EU certification.
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 regulations.
How we can help you apply the EU MDR requirements
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.
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.
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.
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.
Meet our expert
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.