Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)
Staying Compliant: Strategies for EU MDR and Beyond
09 Apr, 2025
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Staying Compliant: Strategies for EU MDR and Beyond
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When: May 22, 2025 | 10:00 AM ET
Where: Online Webinar
How to Register: Sign up here
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Staying compliant with EU Medical Device Regulation (MDR) requires more than just ticking boxes. As the regulatory environment becomes more dynamic and demanding, medical device manufacturers need smarter strategies to maintain certification and minimize compliance risks.
Join Celegence on May 22, 2025, for an expert-led webinar focused on helping regulatory, quality, and compliance professionals overcome common MDR challenges and proactively prepare for future changes.
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What You Will Learn
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- Overcoming Regulatory Hurdles: Understand how regulatory divergence across regions increases operational burden and explore approaches to minimize its impact on compliance and cost.
- Technology-Enabled Efficiency: See how leveraging the right tools and platforms can simplify technical documentation and improve the accuracy and consistency of regulatory deliverables.
- Clinical Evaluation Readiness: Gain insights into creating audit-ready clinical evidence while addressing the evolving expectations of Notified Bodies.
- Future-Proofing Compliance: Stay informed about what’s next in medical device regulations and what actions you can take now to stay aligned and prepared.
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Who Should Attend?
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This webinar is ideal for professionals in the medical device industry, especially those working in:
- Regulatory Affairs
- Quality Assurance
- Compliance and Risk Management
- Clinical Evaluation and Technical Documentation
Whether you’re supporting Class I devices or higher-risk products, this session will provide practical guidance to help your team stay ahead.
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Meet the Experts
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- Dr. Anushree Singh, Manager/Senior SME, Medical Device Services, Celegence
With 13 years in Life Sciences and 5+ years in medical device regulatory writing, Anushree provides strategic guidance on clinical evaluation, PMS, and evidence development under EU MDR. - Dr. Ipshita Chattopadhyaya, Manager/Senior SME, Medical Device Services, Celegence
Ipshita is a regulatory specialist with 8+ years of experience in clinical evaluation and EU MDR compliance across various therapeutic areas, including emergency, orthopedic, and ophthalmic devices.
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Gain a Competitive Advantage – Register Today
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This is your opportunity to gain practical insights from experts actively supporting global medical device manufacturers.
All registrants will receive a recording of the session following the live webinar. Secure your spot and stay one step ahead in regulatory compliance.
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For more information on how Celegence can help improve your regulatory compliance, reach out to us at info@celegence.com, contact us online or read more about Celegence’s services.
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15 Apr, 2025