Navigating EU MedTech Compliance

Are your ready to master the EU MedTech regulatory currents?
The European Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) chart a course for stricter requirements, affecting manufacturers and other stakeholders. This raises many questions from manufacturers concerning their regulatory compliance journey and certification.

Deloitte has developed a guideline in collaboration with the Dutch Ministry of Health, Welfare and Sport, Notified Bodies and manufacturers to support startups and Small and Medium Enterprises (SMEs) in this journey. Join our webinar to learn more about the guideline and discover key insights for navigating MedTech regulations.

Welcome aboard “Navigating EU MedTech Compliance”, the webinar for EU MedTech startups and SMEs aiming to conquer the European market. This is your call to learn more!

Agenda
  • Guideline Overview: A summary for newcomers or a quick refresher.
  • Regulatory Update: Delve into the latest EU MedTech regulatory shifts.
  • Compliance Roadmap: Discover how experienced experts approach regulatory compliance projects.
  • ISO 13485 Certification: Be inspired by a peer's success story in achieving Quality Management System excellence.
  • Q&A: Cease the opportunity to ask questions to fellow MedTech colleagues.
Exclusive Guest speaker: Marco de Boer
We are honored to welcome Marco de Boer, CEO and co-founder of Predica Diagnostics. Under his leadership, Predica Diagnostics has set a benchmark in the diagnostic landscape. They have embarked on a journey to become ISO 13485 certified and now he’s here to illuminate the path for others. Don't miss this chance to learn from Marco and uncover strategies that could help guide your company towards international success.

Why join us?
Expert Navigation: Our seasoned industry colleagues will guide you through the regulatory currents.
Compliance Roadmap: Practical compliance strategies and best practices, with a focus on startups and SMEs.
Exclusive Interview: Exclusive interview with Marco de Boer, CEO & Co-founder of Predica Diagnostics
Interactive Session: Engage in real-time discussions and Q&A sessions with fellow MedTech peers.

Practical Information
Audience: EU MedTech Startups and SMEs
Date: 23 April 2024
Time: 11:00 – 11:45 CET

Embark on your journey to compliance and certification mastery. Your guidance for more clarity in EU Medical Device Compliance awaits!
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Frans Breuer
Senior Manager
T +31 (0)6 8333 0469
E [email protected]

deloitte-nl-paul-van-geffen.jpg
Paul van Geffen
Senior Manager
T +31 (0)6 5018 2007
E [email protected]
 

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