No matter which medical device, whether software, implant, IVD, or substance-based device, no matter which class: With us, all companies have managed to bring their devices to the EU market. You can rely on that.
We create your precise timetable so you know exactly who has to do what and when. We are also happy to provide you with active support. That means you can reliably plan your resources and be sure you won't forget anything.
Take advantage of the opportunity to digitalize your approval with our help. This ensures your long-term conformity and minimizes your regulatory efforts – even in case of product changes.
Request the free Starter Kit to get an overview of all the relevant regulations and standards so that you can quickly and safely get your medical and IVD medical devices approved in the EU market.
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We help you define a precise, regulatory-compliant intended purpose for your devices, qualify and classify your devices based on it, select the appropriate conformity assessment procedure, and create targeted roadmaps.
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We ensure that you have all the necessary device-specific documents and that they meet the market-specific requirements.
From performance or clinical evaluation and investigation to usability, biocompatibility, and electrical safety testing to pentesting – we can take over the planning, implementation, and documentation on request.
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The MDR and IVDR require all medical device manufacturers to have a QM system. We ensure that yours complies with all requirements and that you fulfill the prerequisites for marketing your device.
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Every notified body has strengths and weaknesses. We help you select the one that best suits your device, your company, and your timetable. We can then submit the necessary applications directly.
We compile the relevant laws, standards, and guidelines specifically for your devices and keep you updated on changes.
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Contact us right away to plan the first steps of your EU approval and
determine the duration and costs until CE marking of your device.
Phone
+49 7531 94500 20
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Our team of experts will quickly provide precise and reliable answers to the crucial questions about your MDR approval.
Our team of experts will quickly provide precise and reliable answers to the crucial questions about your IVDR approval.
Be safe with our readiness check and accelerate your MDR or IVDR conformity assessment by a notified body.
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