NIS2 · MDR/IVDR · GxP · ISO 13485
Cybersecurity for Pharma & MedTech
Pharmaceutical manufacturers, medical device manufacturers, and diagnostics companies operate in one of the most heavily regulated environments there is: NIS2, MDR, IVDR, GxP, ISO 13485, FDA 21 CFR Part 11, and EU-GMP Annex 11. At the same time, they are attractive targets for IP theft, production sabotage, and supply chain attacks. We provide awareness training, phishing simulations, vulnerability management, and a managed SOC—tailored to validated systems and audit-ready documentation.
TYPICAL ATTACK SCENARIOS
Four attack vectors that specifically target pharma and medtech.
The threat landscape is different from other industries — IP, OT networks, clinical trial data, and deeply integrated supply chains create their own attack patterns that require targeted defense.
OUR SOLUTIONS
Security that respects validated systems.
In GxP-regulated environments, standard security tools fall short of change control and validation requirements. Our program is designed to improve security without compromising the validated status of your systems — with documentation that stands up to audits.
Continuous training
Phishing Simulation as a Service
Industry-specific bait: fake notified body notices, CDMO invoices, regulatory update emails, internal clinical data requests. Measured by department — R&D, QA, Production, Sales. Proof of effectiveness for awareness obligations under NIS2, MDR, and ISO 13485.
Employee Resilience
Security Awareness Training
Role-based training for R&D, production, QA, clinical, regulatory affairs, and sales. Content on IP protection, insider risks, and training on the proper use of USB drives and laboratory equipment. Training records directly usable for ISO 13485, GxP, and NIS2 audits.
Know the attack surface
Vulnerability Management
Asset discovery for OT networks too: SCADA, MES, batch control, LIMS, LabWare. Passive scanning modes for validated systems, active scans only within defined maintenance windows with change-control integration. Remediation tracking that does not compromise qualification status.
24/7 Managed SOC
Incident Detection & Response
Monitoring across IT and OT segments, detection of APT-typical patterns (lateral movement, slow exfiltration, manipulated build pipelines). Prepared reporting documents in accordance with § 32 BSIG for NIS2 and MDR reports to BfArM/notified bodies — within the tight MDR deadlines.
WHY ENTROPY CS
Cybersecurity that understands GxP, validation, and audits.
Generic security service providers run into problems in regulated environments because of validation status. GxP validation specialists, in turn, have no operational security program. We combine both worlds.
Validation-compatible
Our processes are aligned with Change Control, Change Impact Assessment, and qualification requirements. Every security measure is documented in an audit-ready way—no surprises at the next FDA, EMA, or BfArM inspection.
IT and OT perspective
We bring a genuine understanding of the specifics of OT environments — SCADA, MES, lab automation, batch control. No brute-force methods that destroy batches or cost you validation status.
Compliance multi-use
The evidence from our services simultaneously covers NIS2 risk management, MDR cybersecurity documentation, ISO 13485 QMS requirements, and GxP validation evidence. Created once, used multiple times.
The questions we regularly hear from Quality, Compliance, IT leaders and CISOs in pharmaceutical and MedTech companies.