Prepare for change
in 3 steps
MEDICAL DEVICE REGULATION
IDENTIFY THE CLASS OF YOUR MEDICAL DEVICE
Start by defining the intended use of your software, so you can learn which standards it needs to comply with. This will help you to identify your software’s class too. As part of the MDR coming into force in a few months, almost all software-driven medical devices or apps will be up-classified into Class IIa or Class III. Read Rule 11 of the MDR for more information.
DIVE DEEP INTO THE MDR
The only way to fully understand MDR is to study it inside-out! Make sure to take notes on where it will impact you. Reading our guidebook “Medical Devices Regulation 2020 - Everything You Need to Know” is a good starting point: it summarises what will change and what will stay the same.
CREATE A COMPREHENSIVE PLAN
This will be a major task; one that, again, our guide can help you prepare for. Start by compiling a list of tasks, and don’t forget to include a timeline and to map out resource allocation. To give you a head start, here are a few examples of the must-dos:
• Put in place a quality management system
• Assign a team responsible for ensuring compliance with the new regulation
• Create a risk management system
• Define a process for your software’s clinical evaluation
• Establish a post-market surveillance plan
FIND THE RIGHT PARTNER TO HELP YOU UNDERSTAND AND IMPLEMENT SOME OF THESE CHANGES
Critical Software has over twenty years’ experience in software development and testing for the most demanding industries and regulations. With our knowledge of medical device standards, like the EU’s new Medical Device Regulation and IEC 62304, we’re in a unique position to tackle the challenges medical device manufacturers face. Our software development, testing and certification expertise ensures full compliance with industry standards – right up to Class III devices.
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