Topical Article

Guide for start-ups – Regulatory Affairs & Design Assurance essentials

Posted on by Congenius

Start-ups that want to bring a medical device to market are inevitably confronted with a plethora of questions regarding compliant product development. With often limited time and budget, adhering to the many industry regulations can prove challenging. Prioritisation of the “strictly necessary” tasks is therefore key to maximise efficiency on the journey to medical device certification.

Brought to you by our CEO Jörg Dogwiler, our free whitepaper provides start-ups with a digestible guide for how to develop their medical devices according to EU MDR 2017/745 including the most relevant harmonized standards. With a focus on those tasks that ensure compliance, the resource outlines how the process related to the sequence of these tasks normally works.

Whilst the approach for other markets is very similar to what we outline, this whitepaper – available to download below, is focused primarily on compliance with the EU MDR.

Can’t see the whitepaper? Simply log in, or subscribe to our Knowledge update for full access to all content from our MedTech experts.

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For more information on the full breadth of our Regulatory services, see here.

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