Preparing for EU MDR Product Submissions: A Sustainable Approach



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.

Download your copy of the eBook to start establishing a foundation for compliance and a competitive advantage.

Michelle Boucher: Selection Guide For The Medical Device IndustryMichelle Boucher is the Vice President of Research for Tech-Clarity. Michelle has spent over 20 years in various roles in engineering, marketing, management, and as an analyst. She has broad experience with topics such as product design, simulation, systems engineering, mechatronics, embedded systems, PCB design, improving product performance, process improvement, and mass customization. Ms. Boucher is an experienced researcher and author and has benchmarked over 7000 product development professionals and published over 90 reports on product development best practices. She focuses on helping companies manage the complexity of today’s products, markets, design environments, and value chains to achieve higher profitability.