Verification and Validation on the Horizon?
A Practical Guide
ARE YOU READY?
Have you clearly defined what success looks like for your device?
Are your user needs specific enough to guide meaningful testing?
Do you have a plan to learn from testing—not just to pass it?
For medtech developers, the words “verification and validation” can evoke a mix of anticipation and uncertainty, especially if you’re new to the field. What lies on the horizon for your medical device? Are your foundations strong enough to navigate the road ahead?
In episode 392 of the Global Medical Device Podcast, Devon Campbell joined host Etienne Nichols to explore the realities of verification and validation (V&V). Their conversation focused on simplifying these critical processes, avoiding heavy FDA or ISO jargon, and breaking down practical strategies in plain, accessible terms.
Whether you’re grappling with regulatory compliance, medical device design controls, or user needs, this episode offers actionable insights to help you navigate V&V with confidence.
Speaking Plainly, Thinking Practically
Throughout the discussion, Devon and Etienne made a point to avoid regulation-heavy language, focusing instead on what startups need to know in practical terms. Complex processes like design inputs, design outputs, and pre-verification testing were explained in ways that make sense for teams without years of regulatory experience.
For instance, they described verification as ensuring your product was built correctly and validation as proving it’s the right product for your users. This straightforward approach underscores the importance of clarity—not just for passing audits, but for building confidence across your team and stakeholders.
Looking Beyond the Horizon
What’s your next step after verification and validation? The podcast explored how V&V doesn’t just prove compliance—it builds trust with your users and sets the stage for long-term success.
Whether it’s refining your approach to design reviews, addressing regulatory challenges, or thinking globally about your device’s lifecycle, the insights shared in this episode can help you think bigger.
Verification and validation might feel daunting
What’s your biggest challenge as you prepare for V&V?
Are there gaps in your process you’re unsure how to address?
What’s worked (or not worked) for you in your own V&V experience?
You don’t have to do it alone. We’re here to help.
Memorable Quotes
“Think of verification as proving you built it right, and validation as proving you built the right thing. It’s the ultimate double-check—no shortcuts allowed!”
“You can’t just say ‘the user wants it to be easy to use’—who’s the user? The doctor? The technician? The patient’s dog? Be specific, or validation will eat you alive.”
“Pre-verification is like a dress rehearsal. You don’t want to find out on opening night that the props don’t work, the script has typos, or the stage is missing a step.”
“A good design review isn’t just a meeting to check a box. It’s your chance to fix what’s broken, celebrate what’s working, and make sure you don’t miss something obvious—like the fact that you forgot the ‘on’ switch.”
Learn More
↗ Voice of the Customer
↗ Building Startup Quality Culture
↗ Verification and Validation (Training)
↗ Requirements Management - Best Practices for Medical Device Companies (Training)
Let’s Continue the Conversation
We’d love to hear from you! Reach out to our team to discuss how we can support you on your journey.
