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Date
28th to 30th of April 2025
Duration
3 session online (1:30 hour / per session)
+
1 session online (IVD 1:30 hour; included in pack 2)
Language
English
Location
Online
Applications
Open
Price
Pack 1 - €1,229.02
Pack 2- €1,976.37
Application deadline: 10th of April 2025
For more information, contact: ricardo.ribeiro@bgi.pt
Welcome to our online course focusing on Regulatory Affairs for Medical Devices*!
Whether you're part of a Health Tech startup or a Research Group working on innovative medical devices, this course is tailored to help you navigate the complex regulatory landscape governing medical devices, specifically through FDA requirements in the US.
Through expert-led sessions, interactive discussions, and personalized 1:1 mentoring, this course is designed to guide you step-by-step through the regulatory pathway, empowering you to master compliance requirements and confidently navigate the process of bringing your products to market.
This course is an excellent opportunity to expand your knowledge and network with an expert in the field. Don’t miss out on the chance to accelerate your journey from development to commercialization!
Senior Vice President of Regulatory and Clinical Affairs at AlvaMed
Has 40 years of experience providing regulatory and clinical support for medical device companies. His expertise focuses on implementing creative regulatory and clinical strategies from development through commercialization, with experience in multiple therapeutic areas both in the US and abroad.
Eric holds a B.S. in Microbiology from the University of Maine at Orono and is a member of the Regulatory Affairs Professionals Society (RAPS).
By participating in Regulatory Affairs for Medical Devices, you will:
• Gain expert insights into the latest regulatory frameworks and compliance requirements for medical devices.
• Work on regulatory challenges and learn how to navigate approval processes efficiently.
• Analyse strategies to ensure compliance, minimize risks, and accelerate market entry.
Regulatory Affairs for Medical Devices is designed for:
The Regulatory Affairs for Medical Devices mini-course is tailored for Health Tech startups and Research Teams aiming to fast-track their transition from development to market launch and succeed!
• Regulatory Frameworks & Compliance – Key steps from development to market, including FDA pathways and approvals.
• Device Classification: Understand risk-based classifications (Class I, II, III) and submission requirements.
• Quality Management System (QMS): Requirements for design, manufacturing, and compliance.
• Approval & Certification Processes – Navigating clinical evaluations, risk assessments, and conformity assessments.
• Post-Market Compliance: Handling registration, safety monitoring, and reporting.
• IVD Regulations (included in pack 2): Learn FDA guidelines for IVDs, including classification, labeling, and approval.
