The seven pillars our blog covers.
Each pillar bundles the services, in-depth guides, glossary entries, and curated blog posts that make up our coverage of that topic.
FDA Premarket Cybersecurity
Everything a MedTech team needs to clear FDA premarket cybersecurity review under Feb 2026 guidance and Section 524B - services, guides, FAQs.
- · Cybersecurity Before MVP vs After Market
- · 510(k) Cybersecurity Requirements Every Maker Must Meet
- · A New Era for Quality and Safety
- · 21 CFR Part 820 and Medical Device Cybersecurity
Medical Device Penetration Testing
Pen testing built for FDA submissions and connected medical devices - black, gray, and white box methods, scoping, and the standards that map to each.
- · Security Requirements Testing vs Penetration Testing
- · Medical Device Abuse & Misuse Testing
- · A Comprehensive Guide to Software Testing for Medical Devices
- · Risk-Based Testing for Medical Device Software
SBOMs for Medical Devices
FDA-compliant SBOM generation, CVE/KEV monitoring, and the formats (SPDX, CycloneDX) reviewers expect in 510(k), De Novo, PMA, and IDE submissions.
- · Medical Device Cybersecurity: 2026 Best Practices Guide
Threat Modeling for Medical Devices
Threat models that hold up under FDA review - STRIDE applied to connected and implantable devices, AAMI SW96 alignment, and the gaps reviewers flag most often.
- · Home Use vs Hospital Device Cybersecurity Requirements
- · FMEA vs Threat Modeling for Medical
- · Threat Modeling Connected & Implantable Devices
Postmarket Medical Device Cybersecurity
Vulnerability monitoring, CVD intake, patching, and FDA reporting for cleared devices - the postmarket program Section 524B now requires.
- · Medical Device Cybersecurity: 2026 Best Practices Guide
- · Conducting a Medical Device Security Audit
MedTech Cybersecurity Standards
FDA guidance, AAMI, ISO, IEC, and NIST standards that govern medical device cybersecurity - what each one requires and how they connect.
- · A New Era for Quality and Safety
- · 21 CFR Part 820 and Medical Device Cybersecurity
IDE Cybersecurity
Cybersecurity for FDA IDE submissions: what reviewers expect, how to avoid a Clinical Hold, and how artifacts roll forward into 510(k), De Novo, or PMA.
- · FDA IDE Cybersecurity Requirements: 2026
- · Threat Modeling Connected & Implantable Devices
- · Medical Device Safety vs Security Risks
510(k) Cybersecurity
Cybersecurity for FDA 510(k) submissions under the Feb 2026 guidance and Section 524B: what reviewers expect, common deficiencies, and how to ship clean.
- · Home Use vs Hospital Device Cybersecurity Requirements
- · Indications for Use, Predicates, and Cybersecurity Scope
- · FDA SIR Cybersecurity Response: eSTAR Prep Guide
- · Does Device Class Decide FDA
Software as a Medical Device (SaMD) Cybersecurity
Cybersecurity for Software as a Medical Device (SaMD) - cloud, mobile, and standalone software under FDA 2026 guidance, IEC 62304/81001-5-1, and Section 524B.
- · SaMD vs SiMD: What Manufacturers Need to Know
- · What Is Software as a Medical Device?
- · Risk-Based Testing for Medical Device Software
Coordinated Vulnerability Disclosure (CVD)
Coordinated Vulnerability Disclosure for medical devices: CVD policy, intake, triage, and remediation under FDA postmarket guidance and ISO/IEC 29147.
- · FDA Postmarket Cybersecurity for Cleared
- · Medical Device Vulnerability Testing
- · SBOM + SAST for FDA Compliance
PMA Cybersecurity
Cybersecurity evidence for Class III PMA submissions: SPDF artifacts, threat modeling, SBOM, pen testing, and PMA-supplement change control under the FDA's 2026 guidance.
- · PMA Supplement Cybersecurity Changes
- · Letter to File vs New 510(k)
- · FDA Cybersecurity Deficiencies Triggers
- · FDA Medical Device Submission Costs
AI/ML Medical Device Cybersecurity
Cybersecurity for AI/ML medical devices: PCCP, GMLP, model evasion, data poisoning, model inversion, performance drift, and the FDA's expectations under the 2026 guidance and 2025 draft AI guidance.
- · FDA & AI Pen Testing for Medical Devices
- · How to Respond to an FDA Cybersecurity
- · Training Data Poisoning in Medical AI: Controls and Evidence
- · Medical Device AI Evasion & Cybersecurity
Medical Device Cryptography and Trusted Updates
Keys, certificates, code signing, secure update delivery, and post-quantum planning for FDA-regulated medical devices, with the evidence reviewers expect.
- · Patch and Update Mechanism Testing
- · Secure Update Infrastructure for Medical
- · Medical Device OTA Update Vulnerabilities
- · Medical Device Code, Data, and Execution
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