Why Qscription is starting a blog: field notes from FDA-regulated MedTech, tooling walkthroughs, and reactions to regulatory developments as they land.
A short note on why we're here
We've spent the last several years helping AI medical-device founders cross the gap between a working prototype and a product the US market can actually buy. The questions we get asked privately (about FDA pathways, about the operational mess of clinical deployment, about how to make Part 11 evidence boring instead of terrifying) deserve to be answered in public.
So we're starting this blog. Three reasons:
- Pattern recognition is the whole game. A single founder sees one or two submissions in their career. We see them weekly. If a pattern is showing up across teams, that's worth writing down.
- Regulatory rumor outpaces fact. FDA guidance documents change. PCCP templates evolve. We want a place to react to changes within hours, not wait for the next conference panel.
- We don't want to be a black box. Prospective clients deserve to read our thinking before they buy a call.
What you can expect
- Field notes on submissions we've shepherded through 510(k), De Novo, and PCCP review: anonymized, but specific.
- Tooling walkthroughs: how we structure CAPA logs, what we look for in a vendor BAA, how we set up an audit trail that survives an FDA inspector reading it cold at 9am.
- Hot takes on guidance documents and policy changes when they land.
- The occasional explainer for builders who are new to all of this and
need to know what
21 CFR Part 820actually says without reading 30,000 words.
Cadence
Twice a month, more during regulatory news cycles. We'd rather post fewer, better essays than chase a daily rhythm.
If you have a topic you want covered, send it via our contact form. We read everything.