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Complimentary Webinar
December 5, 2023 | 1:00 pm ET (US)
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Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification
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The European Medical Device Regulation (EU MDR) introduced significant changes for medical device manufacturers. Obtaining device certification to demonstrate compliance to EU MDR requires significant investment, both in terms of an organization's resources and budget. Most companies see the certification as an endpoint, but in reality, this milestone to establish the device is just the first in the journey to continuously demonstrate compliance and maintain certification.
Companies must properly assess and understand the key process requirements to continue to comply with EU MDR so that they can evaluate the capabilities of allocated resources, budget, and tools. Efficient application of resources following the major projects that drive the EU MDR certification is critical to keep pace and demonstrate the ability to maintain compliance. Manufacturers who discover too late that their systems are under-resourced risk financial burdens, audit findings, and even losing the certification.
Join Hilde Viroux, Consulting Director at PA Consulting, and Adam Price, Director or Product, at Rimsys for a discussion about the elements of successful post- EU MDR compliance and:
• EU MDR requirements post certification
• Key challenges organizations face
• Considerations to make when assessing your organization's preparedness
WHO SHOULD ATTEND:
- Regulatory Affairs Professionals in the MedTech Industry
SPEAKER
Hilde Viroux
Consulting Director
PA Consulting
Hilde is a senior leader with a broad experience in Regulatory, Quality, Manufacturing, Supply Chain and project management in the pharma and devices industry. She is a leading expert on the European Medical Devices Regulation, combining the regulatory expertise with management of the implementation for a major medical devices company and consulting for most out of the top 10 medical devices companies.
Hilde has an outstanding track record on successful implementation of major projects and building up new capabilities within an organization. She is a natural leader who also performs well in a team and enjoys coaching and developing new talent. She is a strategic thinker focusing on long term solutions. Hilde has an MSc in Medical Technology Regulatory Affairs from Cranfield University in the UK, and BS in biochemistry engineering.
Adam Price
Director of Product, Post-Market
Rimsys
Adam Price has over 17 years of medical device industry experience as a quality assurance and regulatory affairs professional. As Director of Product, Post-Market at Rimsys, Adam is responsible for the strategy and implementation of all post-market surveillance activities within the Rimsys platform, which enable medical device manufacturers to efficiently monitor device performance in the field, assure product safety and efficacy, and maintain compliance with new and changing global regulations. Prior to joining Rimsys, Adam was the Head of Post Market Surveillance & Service Quality at Philips Healthcare. While at Philips, he focused on the development of post-market strategies and solutions that allowed the businesses he supported to meet the complex demands of the global market. Adam holds a Bachelor of Science in mechanical engineering as well as a Master of Business Administration (MBA) from the University of Pittsburgh.
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