If you’re developing a medical device, chances are you’ve lost sleep over regulations more than once. MDR, CE marking, certification; it can feel overwhelming.
I’ve been there.
I’ve sat on both sides of the table, first as a medical doctor, then as a medical device innovator, and now as the founder of a consultancy that helps healthtech teams get their devices certified and market-ready. And I’ll tell you this:
Regulation isn’t your problem. It’s your opportunity.
Leaning into the regulations early could be the smartest move you make.
That’s why I’m excited to join forces with Dr. Zhong Wei Khor, co-founder of Medical Consulting Group, for an upcoming LinkedIn Live session on Thursday 5th June 2025, tailored specifically for healthtech founders. Together, we’ll break down the real-world steps to navigating regulatory hurdles and, more importantly, show you how to turn that complexity into a strategic advantage.
You can sign-up for notifications on LinkedIn to be reminded when this webinar starts.
What We’ll Cover (and Why It Matters)
In this session we will break down:
- What actually qualifies as a medical device
Determining whether your innovation meets the definition of a medical device isn’t always straightforward. Gaining clarity early can make all the difference, helping you plan strategically and set a clear path forward. - How early-stage founders should prepare for MDR
Starting early isn’t just beneficial, it’s critical to ensuring a smoother, faster route to market. - A step-by-step guide to certification
We’ll walk you through the certification process, what to do, when to do it, and how to navigate each stage with confidence. - Evidence requirements and costs behind certification A straightforward overview of the evidence required, associated costs, and practical steps to help you budget effectively and avoid unexpected setbacks.
We’ll also open the floor to live questions, so if you have something specific you want answered, be sure to bring it with you.
Why This Conversation Matters More Than Ever
Healthtech innovation holds incredible promise for solving healthcare’s toughest challenges. But no matter how brilliant your device is, it won’t reach patients unless you understand and navigate the regulatory landscape.
Regulatory knowledge can be a powerful tool, demonstrating that your product meets strict safety and performance standards and is reliable and effective. It also gives you the authority to make medical claims that resonate with clinicians, investors, and patients alike.
By mastering the regulatory process, you not only secure market access but also gain a significant competitive edge. You build trust, differentiate your device, and position your innovation to succeed commercially.
In short, understanding the regulations isn’t just compliance, it’s a strategic advantage that can propel your product from concept to market leader.
Why You Should Join Us
Whether you’re just starting to out or are deep into development, this session is designed to give you clarity and confidence around the regulatory process.
Join us to ask questions, challenge assumptions, and get practical answers that will help you move forward faster and smarter.
📅 Date: Thursday 5th June 2025
🕒 Time: 3 pm BST
🔗 Link: https://www.linkedin.com/events/7333805621110054912/about/
We’ll see you there!
