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Key Regulatory Insights for US & EU Market Access

Language : English

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Location

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Feb 18 , 2025, 11:00-12:00 UTC-05:00 ^?

Online
Price on request

Online

Price on request

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Navigating the regulatory landscapes of the US and EU can be daunting. Join our free webinar to gain actionable insights on key differences and similarities in medical device regulations. Learn strategic approaches to streamline market approval and ensure compliance with the latest standards.

Key takeaways

Understand the similarities and differences in US and EU regulations.
Navigate market approval pathways effectively.
Optimize your design, development, and supplier selection processes.
Leverage strategies for faster approvals and successful market entry.

Course details:

Duration: 1 Hour + Q&A

Delivery: online

Target audience:

Professionals in the medical device industry, including regulatory affairs specialists, quality assurance teams, manufacturers, startups, consultants, and legal experts aiming to navigate FDA and MDR approval processes.

Prerequisites

No prior expertise required or basic knowledge of medical device regulations - ideal for anyone interested in understanding the FDA and MDR approval processes, from beginners to industry professionals. Suitable for all roles in the medical device sector.

By the end of this webinar, you will be able to:

Identify Key Regulatory Differences:

Recognize the primary differences and similarities in medical device regulations between the US and EU markets.

Navigate Market Entry Pathways:

Understand the classification systems, submission processes, and approval pathways for medical devices in both jurisdictions.

Optimize Compliance Strategies:

Apply strategic approaches to minimize delays, such as leveraging pre-submission meetings, modular submissions, and MDSAP audits.

Enhance Design and Development Processes:

Align design, clinical trials, and supplier selection with regulatory expectations to streamline approvals and ensure compliance.

Understand Post-Market Requirements:

Plan for post-market surveillance and reporting to maintain device compliance across jurisdictions.

Leverage Tools for Faster Approvals:

Utilize innovative regulatory strategies, such as structured dialogues and equivalence claims, to expedite approvals.