EU MDR Strategies: How To Achieve Market Advantage While Streamlining Regulatory Compliance

An On-Demand Webinar Presented in Conjunction with Kalypso

The European medical device industry is undergoing a transformation as the new European Medical Device Regulation is set to replace Medical Device Directives (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC) by 2020.

The European Union Medical Device Regulation (EU MDR), which was published in the Official Journal of the European Union on May 5th, 2017, is aimed at restoring confidence in the European regulatory system after widespread safety issues and corrupt Notified Body engagements. These regulations are directed to increase post-market surveillance, expand the use of Unique Device Identifiers and provide better oversight of Notified Bodies.

Access the webinar recording and listen in as we discuss:

  • EU MDR Background
  • Industry Challenges
  • Our Infographic on EU MDR
  • Why Digital Transformation is Necessary for EU MDR and Beyond
  • Role-Based Apps and PLI Algorithms
  • A New Approach to EU MDR Compliance

David Wolf, Senior Manager at Kalypso pointed out, “IoT Apps are allowing companies to mashup data from multiple systems in a more agile and less expensive manner then traditional integration methodologies.  These role-based apps allow companies to break down the barriers between Product Development, Document Control, Quality, Regulatory and Service departments.”

From a business perspective, resource constraints, adequate knowledge of the regulation and older products are major concerns for manufacturers.  On the technology side, disparate and siloed or paper-based systems continue to plague medical device manufacturers since EU MDR requires a data-intensive total product lifecycle management.

Wolf concluded with, “To stay competitive and keep up with the evolving regulatory changes, companies will need to pioneer cutting edge software solutions while consolidating source systems.  By expediting new capabilities and having greater maturity in PLM with cleaner, more consolidated product data, the best in class companies can capitalize on key role-based apps and advanced analytic use cases.  This helps medical device manufacturers become more flexible and responsive when responding to new regulations, with the additional benefit of creating a repeatable process that can be utilized the next time a regulation is published.”

The webinar recording is now available on-demand.  You can access it here:

EU MDR Strategies: How to Achieve a Market Advantage While Streamlining Regulatory Compliance

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