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Building Medical Device Software?
Let's Clear Up the Confusion First.
Mini glossary (operator-friendly)
- Concept Pillar
- A Wikipedia-style explainer page that defines the topic and links out to related hubs and pages. You're reading: Appraisers.
- Hub
- A directory page that groups many related pages (and points back up to the concept).
- Leaf Page
- A specific "problem + solution" page built to match a real query. It should always link back to the concept for trust.
FDA compliance, IEC 62304, SaMD classification, quality systems — these topics stress out great engineering teams. This hub collects plain-language answers to the questions that matter most, before you pay a consultant to say them slowly.
Is My Software a Medical Device?
The FDA's definition is broader than most teams expect. Start here.
Is This Class I, II, or III?
Risk classification determines everything — your pathway, your timeline, your cost.
SaMD vs. Internal Software
Software as a Medical Device has different rules than software used in a device. Know the difference.
Do We Need IEC 62304?
Probably yes — but how much depends on your classification. Plain answer here.
HIPAA vs. FDA Software Rules
They overlap but they're not the same. This confuses a lot of teams building health tech.
Risk Management for Software
ISO 14971 applied to software — what you actually need vs. what consultants over-engineer.
Documentation That Actually Matters
Cut through the binder-and-template approach. Here's what auditors actually look at.
What the FDA Actually Cares About
Less scary than the CFR makes it look. Focus on what moves the needle.
What Breaks FDA Audits First
The most common failure points — and how to not be that team.
FDA Software Questions Startups Ask
The questions no one wants to sound dumb asking. Answered honestly.
Software Changes and Updates
When do changes trigger a new 510(k)? More nuanced than a yes/no — here's the framework.
Pre-Market vs. Post-Market Software
Your obligations don't end at clearance. What ongoing software oversight looks like.
Quality System and Software's Role
How software development fits inside a 21 CFR Part 820 / ISO 13485 QMS.
Internal Tools vs. Commercial Software
Your internal manufacturing tool might be regulated too. Here's how to check.
We Already Shipped. Now What?
You're not the first team to ship first and ask compliance questions later. Practical path forward.
Medical Device Software Mistakes
The patterns that cause pain — and the mindset shifts that help.
Readiness Check
A plain-language self-assessment before you talk to a notified body or FDA.
Compliance Map
A visual overview of how the standards, regulations, and processes connect.
Get Help With Medical Device Software
When you need a human who's been through this — not just a checklist.
When Not to Build Regulated Software
Sometimes the honest answer is: don't go regulated yet. Here's when that's true.
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