Preparing for EU MDR Product Submissions: A Sustainable Approach

By Michelle Boucher, VP of Research for Tech-Clarity

Every medical device company wanting to do business in Europe must comply with the new EU MDR regulation. Yet this is no small feat considering the more stringent requirements. While the new regulation is largely an extension of the existing regulation, it requires far more data. As a result, companies must competently manage data throughout the product lifecycle – and update it as their product changes.

Rather than see this is a challenge, Michelle Boucher, VP of Research for Tech-Clarity, views this as an opportunity. Download the guide she authored to position your company for a long-term advantage.

The guide covers all the essential details you need to understand the data requirements of EU MDR product submissions and how to comply. You’ll find guidance on:

• Determining your strategy to collect data and prepare submissions.
• Prepping your product data for the new regulation.
• Overcoming the obstacles that make data submissions challenging.
• Taking advantage of the power of Product Lifecycle Management.
• Five steps to adopting a product-centric approach.

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