MDR transfer of an AED
Corscience helps create an efficient pathway to MDR conformity for a Class III medical device.
Gaining MDR (Medical Device Regulation) approval can be challenging. And when the approval is for a medical device in risk class III – as is the case with this AED (automated external defibrillator) – things can quickly get very complicated. Delays are commonplace, making the approval process very costly. As an MDR-certified development service provider and manufacturer, Corscience helps medical technology companies to overcome the hurdle of MDR approval faster and efficiently.
One of our long-standing customers commissioned us to get an MDD-approved AED ready for MDR certification, thereby ensuring that a life-saving medical device would be available on the European market.
The scope of our consultancy services
To achieve the goal of MDR conformity, our regulatory affairs experts start by looking at our client’s internal data structures and analyzing the technical documentation for the AED.
They focus on the following in particular:
• Updating and supplementing the standards
• Consultation with testing companies regarding any outdated or missing certificates
• Reviewing all the underlying safety and performance requirements under MDR
• Revising the risk management file
• Creating a clear and transparent requirements traceability matrix
• Gap analyses with regard to mechanisms, software and production
• Reviewing the biocompatibility test reports
Updating standards for a smooth approval process
Updating and supplementing the standards in the device master record (DMR) are crucial steps for a smooth MDR transition. As part of this process, our MDR experts compare all existing standards with the current status – if any changes or modifications are made to a standard, they must be reviewed again by an independent testing provider (delta testing). As a professional defibrillation and AED specialist, we are on hand to provide the testing companies with support when carrying out these follow-up tests.
Comprehensive in-house testing facilities
The compatibility of accessories and systems is of particular importance for MDR approval. Our in-house system testing department enables us to carry out compatibility verification tests and material compatibility tests for our clients internally. We have comprehensive testing equipment, such as mopping robots, for carrying out automated tests.
Would you like to obtain MDR approval for your MDD-approved medical device? Are you looking to bring a new medical device to the market in compliance with MDR? With our many years of experience and our dedicated consulting business unit, we are able to respond flexibly to client inquiries.
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As a defibrillation specialist with over 20 years of experience in the development and approval of medical devices, we will find the right solution for you. Make an appointment to clarify first questions.