ISO 13485 compliance can be a single Notion page. We just received ours at Nervotec, a company I previously worked for as a Product Manager. 🎉

As the ISO project lead, I was excited to hear the news just days before moving on to my new chapter.

For those unfamiliar, ISO 13485 is the regulatory standard for Medical Device quality management systems. It's almost a prerequisite for startups in healthcare, often determining market entry, but can be a beast of a certification.

How beastly are we talking?

Imagine a standard with 8 sections and over 100 sub-clauses. Each demands procedure summaries, instructions, and records - all with unique identifiers needing constant updates.

A bigger problem is such records usually sit in Google Drive, requiring updates to be largely manual. Someone inevitably becomes a reluctant document police.

We needed a better solution, and that's why, a new platform.

Everything was re-created under Notion, streamlined and automated as I experimented with different tools. This ultimately condensed all requirements into a single Notion page with five inline databases. Records were automatically pulled in, labeled, and organized as they were created.

This is possibly one of the first Notion-based quality management systems out there—and it got us certified.

But the journey to be compliant was so much more than a Notion-based system.

There were many takeaways that stuck with me, and here are a few:

Software as Medical Device (SaMD) is a relatively new territory for ISO, especially with the AI component.

I found this awareness useful to navigate grey areas while staying true to the core product.
ISO is a helpful anchor to company-wide restructuring. We used ISO to optimize our processes, and it was effective.

Automated workflow makes it easy to automate document control, which means easier compliance.
Once we cracked ISO, FDA and HSA felt like déjà vu.

The process is more repeatable than I initially thought. Here, I see real opportunity to make AI-driven streamlining across regulatory bodies possible.
A Notion-based platform for quality management is useful, and a great start to more effective tools.

Building this got me thinking of a few ways to make the workflow even simpler, with or without Notion.

Plowing through regulatory compliance firsthand for the past 1.5 years, I spent a lot of time thinking about how to simplify it. There's a clear need for better tools and automation—partly why I chose my next chapter to be directly in the AI space.

While I'm moving on from Nervotec and the healthcare sector (for now 😉), I plan to keep working on the side for ways to make regulatory compliance manageable for companies, particularly early-stage startups. Currently building an AI-assisted application for compliance that might be fun!

I will definitely share more as I go.

Ah, and here's the said certificate - seeing is believing:

ISO 13485 Certificate

Automating ISO 13485

How I built one of the first Notion-based automated QMS

Minu Choi

Related Posts

On Building this Website

Briefly About Me