FDA pre-market and post-market cybersecurity is no longer optional, and EU MDR is right behind it. We secure device makers without disrupting validated systems, design history files, or your next submission.
Cybersecurity controls and evidence aligned to QSR, ISO 13485, and FDA pre/post-market guidance.
Hardening and change-control for ERP, MES, PLM, and validated GxP systems without breaking validation.
Help desk, patching, and OT/IT segmentation tuned for regulated manufacturing environments.
24/7 monitoring tuned for IP-theft and ransomware against design and manufacturing systems.
Software bill of materials, CVE tracking, and post-market vulnerability response for connected devices.
Strategic security leadership for early-stage device makers through public manufacturers.
Book a free 30-minute risk call. We'll review your FDA, ISO 13485, and SBOM posture and show you where you're exposed.
Regulated-industry programs built by TRNSFRM.
AS9100, CMMC, ITAR programs for aerospace suppliers.
HIPAA-grade IT for ASCs and outpatient surgery.
TISAX, CMMC, and OEM cyber flow-downs.
HIPAA + 42 CFR Part 2 for behavioral health providers.
CMMC 2.0 & NIST 800-171 for the defense industrial base.
Real HIPAA compliance for dental groups and DSOs.
Deeper reads from the TRNSFRM team.
A pragmatic IR playbook, not a shelf binder.
Where teams get cloud wrong — and how to fix it.
The DIB compliance clock is ticking.
Why voice and video attacks now target execs.
Attackers are getting past MFA — here's how.
Start planning your post-quantum crypto migration.