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Clarity for Innovators
Insights on sustainable healthcare innovation, regulations and circularity.
Practical perspectives, reflections, and structured guidance for founders, innovators, and healthcare professionals navigating sustainability, compliance, and growth. Here you’ll find articles that translate complex topics into clear thinking and actionable next steps.
Where the Real Circular Economy Opportunities Are for MedTech Start-ups (Including MDSW Founders)
In this post, I’ll show you where the real opportunities lie, mapped to different business models - including if you’re building medical device software (MDSW) rather than hardware.
4 days ago4 min read
Why the 9R System Matters - Even If You’re a Founder Buried in MDR
Let’s look at why it matters to you as a MedTech founder. Several new EU regulations are either already in force or coming into effect over the next few years, and they will have implications for medical devices. Switzerland has committed in law to achieving net-zero GHG emissions by 2050. This presents an opportunity for start-ups.
Jul 243 min read
Do You Have a Medical Device with Batteries? Here’s The Deadline You Can’t Afford to Ignore!
The clock is ticking on removability, the Battery Passport and due diligence. Here are the deadlines that matter - and the compliance risk if you miss them.
Jun 172 min read
Preparing for your first audit? Here’s what you should consider.
Many founders are surprised to learn that an initial certification audit requires far more than a QMS sitting on a shared drive. For those navigating ISO 13485 and/or MDR certification for the first time, the gap between “we have an SOP and a template for that” and “we can show the auditor evidence that the SOP is being followed” is routinely underestimated. This post gives a clear overview of what needs to be in place before your first audit and where teams most commonly ru
May 274 min read
Choosing a Notified Body: What MedTech Founders Need to Know
If you’re building a medical device under the EU MDR, picking a Notified Body (NB) is one of the most consequential decisions you’ll make on your road to market. It’s not a procurement exercise you can knock out in an afternoon, and it’s not something you’ll easily undo. The NB you sign with today will likely be your conformity assessment partner for years - through your initial certification, your surveillance audits, and most of your subsequent product changes. So, before
May 184 min read
Where can I buy standards without breaking the bank?
As a medtech coach, I get asked the same questions over and over. So I'm turning the most frequent ones into a post series - starting with a question that I get asked from almost every early-stage founder. Where can I buy standards without breaking the bank? The moment most start-ups search for their first standards, their eyes go wide. Standards are expensive - sometimes shockingly so. But, here’s a tip I share with every founder I coach: the price varies significantly depen
Mar 292 min read
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