Guides, articles, episodes, checklists, and updates - built from 275+ FDA submissions and the standards work behind them.
33 downloadable playbooks on FDA submissions, SPDF, threat modeling, pen testing and more.
Browse guidesField-tested articles on standards, regulations, SDLC, and emerging threats in connected MedTech.
Read the blogThe Med Device Cyber Podcast - practical insights, real threats, and global regulatory updates.
Listen nowOn-demand sessions on FDA premarket cybersecurity, SBOMs, threat modeling, SPDF, and postmarket programs.
Watch webinarsShareable visual explainers on threat modeling, risk assessment, and security architecture - each with a full text version.
View infographicsFDA vs EU MDR vs the Cyber Resilience Act vs NMPA and five more regulators - scope, evidence, SBOM, and postmarket duties side by side.
Compare regulatorsRegulatory and industry updates that change how connected medical devices get cleared.
See updates3 anonymized engagement narratives - challenge, approach, and outcomes from real FDA submissions we supported.
Read case studies10 reviews from MedTech quality, regulatory, and engineering leaders we've worked with.
Read testimonialsStraight answers on pricing, timelines, scoping and what FDA actually expects.
Read FAQsMonthly newsletter on MedTech cybersecurity and FDA updates.
Open collectionConference talks and keynotes on MedTech security.
Open collectionWeekly conversations on MedTech cybersecurity, FDA, SBOMs, and pen testing.
Open collectionOn-demand webinars on FDA cybersecurity and SPDF.
Open collectionFree public resources, podcasts, and mentorship programs Blue Goat Cyber sponsors or supports for the MedTech cybersecurity community.
Judge, sponsor & mentor for APAC MedTech innovators
Blue Goat Cyber proudly gives back to MedTech Innovator APAC as a judge, sponsor, and mentor - helping early-stage MedTech companies across the Asia Pacific region strengthen cybersecurity and FDA-readiness as they scale.
Visit sitePublic timeline of MedTech cyber events
A sourced, public-record timeline of 86+ medical-device cybersecurity events from 1985 to today - recalls, FDA/CISA advisories, and incidents tied to patient harm.
Visit siteConversations with MedTech security leaders
Interviews and field notes for product security, regulatory, and engineering teams shipping safer connected devices.
Visit siteMap controls across MedTech standards
A free crosswalk between FDA guidance, ANSI/AAMI SW96, ISO 13485, ISO 14971, and related frameworks - built to save submission and audit prep time.
Visit siteBite-sized guidance for builders
Short, practical tips for engineers, regulatory leads, and founders working on connected medical devices.
Visit siteAI/ML-enabled SaMD resources
A focused resource on cybersecurity, safety, and regulatory expectations for AI/ML-enabled Software as a Medical Device.
Visit siteDebunking medical device cybersecurity myths
A free public resource that calls out the most common myths about medical device cybersecurity - from "we passed pen testing, so we're FDA-ready" to "SBOMs are just a list." Built to help manufacturers separate marketing from regulatory reality.
Visit sitePlain-English MedTech & cyber glossary
A free, plain-English glossary of medical device, regulatory, and cybersecurity terminology - built to help engineers, regulatory teams, and founders speak the same language as FDA reviewers and notified bodies.
Visit siteStep-by-step playbook for launching a MedTech company
A free, founder-focused guide covering the practical steps to start, fund, and launch a medical device company - from idea validation and regulatory strategy through clinical, reimbursement, and commercialization.
Visit siteHealthcare and humanitarian relief in Pakistan
Blue Goat Cyber proudly supports the APPSUK Foundation - the charitable arm of the Association of Pakistani Physicians and Surgeons of the United Kingdom - funding mobile health units, cataract clinics, prosthetic limbs, education, and disaster relief for underserved communities in Pakistan.
Visit site14-page overview of who we are, our services, methodology, and FDA track record - view in-browser or download the PDF to share with stakeholders.
Single-page 2026 company one-pager: what we deliver, lifecycle stages, proof points, and how to book a scoping call.
Co-deliver with regulatory consultancies, technology vendors, and security firms.
Report a security issue in our services or in a device we support.
How we collect, use, and protect information submitted through this site.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ FDA submissions.
