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[Skip to main content](#main)

[

MedTech Cyber Tips

The Ultimate Guide



](/)

[Home](/)[Find Your Path](/journey)[All Topics](/topics)Reference[About](/about)

Search ⌘K

[All phases](/journey)

Journey phase

# Concept

Defining the device, risks, and security architecture.

5 guides · 47 curated tips

Your journey progress

1 of 5 phases explored · saved on this device 

Reset

1.  [Concept ](/journey/concept)
2.  [Premarket ](/journey/premarket)
3.  [Submission ](/journey/submission)
4.  [Postmarket ](/journey/postmarket)
5.  [Incident ](/journey/incident)

What to focus on

## Topics for the concept phase

[

6 tips 

### Overview

Start here. The big picture for MedTech security.

](/topics/home)[

10 tips 

### Why It Matters

The case for taking cybersecurity seriously: patients, brand, and revenue.

](/topics/why)[

7 tips 

### SPDF

Bake security into every stage of the device lifecycle.

](/topics/spdf)[

12 tips 

### Threat Modeling

Identify and reason about threats before they ship.

](/topics/threatmodel)[

12 tips 

### AI/ML Devices

Adversarial ML, model integrity, PCCPs, and the security surface unique to learning-enabled devices.

](/topics/aiml)

Related resources

## Checklists for concept and premarket

[

Premarket · 6 min read

FDA Premarket Cybersecurity Submission Checklist

Section-by-section checklist mirroring FDA's RTA cybersecurity items: security risk management, SBOM, threat model, testing evidence, labeling, and CVD policy.



](/resources/premarket-cyber-submission-checklist)[

SBOM · 5 min read

SBOM Quality & VEX Readiness Checklist

What every cybersecurity reviewer (FDA or hospital) looks for in an SBOM: format, depth, signatures, hashes, supplier identification, and paired VEX statements.



](/resources/sbom-quality-checklist)

[

Next phase

Premarket



](/journey/premarket)

MedTech Cyber Tips

The organized, end-to-end guide to medical device cybersecurity, from concept through postmarket. Part of the Blue Goat Cyber family.

Topics

-   [Overview](/topics/home)
-   [Why It Matters](/topics/why)
-   [SPDF](/topics/spdf)
-   [Threat Modeling](/topics/threatmodel)
-   [Pentesting](/topics/pentesting)

Reference

-   [Glossary](/glossary)
-   [FDA vs MDR](/compare)
-   [Resources](/resources)
-   [Updates](/updates)
-   [RSS feed](/rss.xml)

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