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.
Those organizations that are non-compliant will be unable to participate in the EU market until they are certified, which was recently estimated to be a market worth €14.11 billion across EU’s ten largest economies, plus Switzerland.
View this webinar to learn key strategies on how to achieve EU MDR compliance, in a staged approach, become an EU MDR pioneer and take market share from competitors.
Sandra K. Rodriguez is a Market Analyst at Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory trends.
She has seventeen years of experience working within the FDA-regulated industries in a variety of roles including sales & marketing and as an analyst for the past three years. She has authored numerous articles and white papers on regulatory topics that impact the future of the Life-Sciences industry. Sandra has also presented primary research findings to FDA officials and is a proud US Army Reserve Veteran.
David Wolf, is a Senior Manager at Kalypso Consulting, and a trusted business advisor with diverse industry experiences specializing in quality management, regulatory management, risk management, design controls, document controls and supplier controls. He has over 25 years of life sciences professional experience including deep experience working to prepare medical device companies with EU MDR implementations. He has released several successful medical device product lines for worldwide distribution, delivered an ISO 13485:2016 Ask the Auditor webinar, and designed, validated and implemented a Medical Device SaaS offering using AWS.
David holds a Mechanical Engineering degree from Colorado School of Mines, is Certified in ISO 14971, as well as a certified Biomedical Auditor (ASQ), and Quality Engineer (ASQ). You can learn more about David including his recent publications on David's Kalypso profile.