How to Use Clinical Data for Medical Device Submissions in both EU & US

This on-demand webinar, hosted by Greenlight Guru, focuses on the complexities and strategies of using clinical data for medical device submissions in both the European Union and the United States.
Watch now to gain valuable insights into the rigorous process of obtaining regulatory approval for medical devices, which requires extensive submission of clinical data to governing bodies.
Main points covered:
1. Prioritizing clinical data for medical device submissions in different geographies, focusing on specific regulatory, marketing, and reimbursement goals.
2. Understanding that regulatory approval is only the first step in the medical device launch process, emphasizing the importance of marketing and reimbursement strategies.
3. The multi-team, multi-step nature of clinical and regulatory development, involving collaborative efforts across various teams.
4. Optimizing clinical study design to maximize the value of clinical data in submissions, with a focus on study protocol, endpoints, and regulatory requirements.
5. Strategies for combining clinical data across multiple geographies, including considerations for device classification, equivalence claims, and data poolability.
Target Audience:
• Small to medium-sized medical device manufacturers with aspirations to enter both US and EU markets.
• Professionals involved in research and development, regulatory affairs, and clinical research organizations (CROs).
• Medical device industry experts and strategists focusing on international market entry.
• Healthcare professionals and academics interested in medical device regulations and clinical data usage.
Access the printable slides for this presentation by visiting:
www.greenlight.guru/webinar/h...