The 5 top pitfalls for early stage Medical Device companies and how to avoid them webinar
OnDemand Webinar
The 5 top pitfalls for early stage Medical Device companies and how to avoid them
Duration: 32 minutes
Summary
Understand the costs and best locations to bring your product to market.
Many entrepreneurs and life science executives believe the EU CE Marking system is the cheapest and quickest option to market as opposed to working on the FDA regulatory pathway and accessing one of the largest device markets in the US.
In today’s era of vast regulatory reform, there are a number of advantages to looking at the US first. Challenges remain with the EU changes to the Medical Device Regulations (MDR) and the backlash surrounding so few Notified Bodies approved to certify new and existing devices.
We will go over:
- How to avoid the most common pitfalls that lead to wasted time and resources
- How to lay the critical foundations for your future advanced trial phases, including the use of real-world data.
- Review key regulatory innovations to clinical research strategies
Read more about the entire series here.
Speaker
Alethea Wieland
President & Founder
Clinical Research Strategies, LLC
Alethea Wieland is founder and president of Clinical Research Strategies, LLC, an executive-level management consulting firm and boutique, functional service provider for the life sciences industry.