Medical Device Cybersecurity Assessment
Medical device cybersecurity assessment helps manufacturers find security gaps in their products before they ever reach the market — so devices are safe from day one, and stay safe long after launch. For healthcare providers, it’s how you confirm that every device in your network isn’t carrying hidden vulnerabilities that could put patients, operations, or sensitive data at risk.
- 93% of healthcare organizations experienced at least one cyberattack in the past year.
- 99% of hospitals are currently managing connected medical devices with known, actively exploited vulnerabilities.
- Regulatory bodies including FDA, MDR/IVDR, HIPAA, and GDPR all impose cybersecurity obligations — and the window to act is now.
Medical Devices and Software We Assess
You deserve a partner who knows the full landscape — not just one device category. INNERLUXES finds and helps fix security issues across connected medical devices and software as a medical device (SaMD). The same teams handle full medical device software development and verification and validation testing. Across 68 projects and 30+ industries, we’ve seen what attackers target — and we know where to look.
Class II Medical Devices
- Medical imaging systems — ultrasound units, MRI scanners, CT imaging devices.
- Monitoring and diagnostic tools — wearable spirometers, ECG patches, hemodynamic monitors.
- Treatment devices — smart insulin pumps, anesthesia systems, infusion pumps, dialysis machines.
- Rehabilitation and home care devices — connected physiotherapy tools, remote vitals monitors.
Class III Medical Devices
- Implantable devices — pacemakers, cochlear implants, cardioverter-defibrillators, neural prostheses.
- Emergency and critical care systems — cardiac ablation units, high-frequency ventilators.
- Critical obstetric electronics — fetal EEG monitors, obstetric data analysis systems.
- Neurostimulation devices — deep brain stimulators, spinal cord stimulation systems.
SaMD (Class I, II, III)
- Monitoring and diagnostic software — AI-driven tools for tumor localization, stroke type classification, vitals analysis.
- Treatment and disease management apps — medication dosing calculators, sleep apnea detection apps.
- Clinical decision support tools — real-time risk scoring engines, remote cardiac monitoring platforms.
- Connected patient engagement platforms — cloud-connected remote monitoring dashboards, adherence tracking systems.
Security Assessment Approaches We Are Confident In
Not every device needs the same approach. We match the method to your situation — and we’re transparent about why.
Security controls audit
We review your existing security setup — hardware and software protections, secure architecture, development lifecycle evaluation, patch management, infrastructure configuration, and security awareness of device users and healthcare staff.
Vulnerability assessment
We scan your full device and infrastructure, manually review results to remove false positives, prioritize vulnerabilities by real-world risk, and deliver a clear remediation roadmap ordered by impact and urgency — with retest confirmation that fixes worked.
Penetration testing
We think like an attacker. We test under black box (zero prior knowledge), gray box (limited access), and white box (full admin and source code access) conditions — covering network-level penetration, firmware, and hardware entry points.
Social engineering testing
Your technology can be perfectly hardened and still fall to a well-crafted email. We simulate phishing attacks, spear phishing, whaling (executive-level), vishing (voice-based), and pretexting scenarios to test the human layer of your defenses.
Risk assessment
We don’t just find problems — we help you understand what they mean. We map threats to each vulnerability, evaluate patient safety impact, classify risks by urgency, and align all findings against FDA, MDR/IVDR, HIPAA, and GDPR requirements.
Not sure which approach fits your situation? Tell us about your device and what’s keeping you up at night. Our team will come back with a straightforward recommendation — no jargon, no pressure. You can also get a quote with our security testing calculator. Reach out →
Oshan Khan
Healthcare Data Analyst
at INNERLUXES
“For medical device security, we go well beyond automated scanning. Every engagement includes manual validation of findings, firmware-level review where hardware allows, and a clear mapping of each vulnerability to its patient safety implications. Regulatory alignment isn’t a checkbox — it’s built into every step.
Selected Security Projects by InnerLuxes
Deliverables You Get Upon Medical Device Cybersecurity Assessment
You’ll never be left guessing what was found or what to do next. Every report is written so your dev team, compliance team, and leadership can all act on it.
Security audit reports, vulnerability assessment reports, penetration testing reports, and a risk assessment summary with full risk control classification. Every report includes detected flaws, compliance gaps, and step-by-step remediation guidelines.
Detailed description of all security controls from manufacturing through distribution, a lifecycle security update and patch plan, and guidelines on cybersecurity controls for your intended use environment — including firewall, SIEM, and antivirus configuration.
If remediation changes your device software, FDA or an MDR/IVDR Notified Body may need to be informed. We prepare a full vulnerability description, all software changes with comparison to the previously approved version, a documented rationale, and related device references.
INNERLUXES as a Responsible Healthcare Security Partner
What makes us different isn’t just what we know — it’s how we work. Over we’ve grown a team of 132+ IT professionals who’ve delivered 68 projects across 30+ industries — including some of the most compliance-heavy environments in healthcare and medtech.
Deep expertise
Not generalists — specialists. A track record in software development with a strong portfolio in regulated healthcare and medtech environments.
132+ IT professionals
Across security, compliance, and healthcare IT — including IoT ecosystems and cloud services — with cross-sector threat intelligence that informs every engagement.
Quality & security built in
Established quality management aligned with medical-device and SaMD requirements, backed by a certified security management system. Certified for quality performance and on-time delivery.
Multi-regulation coverage
FDA, MDR/IVDR, HIPAA, and GDPR alignment in a single integrated view — not four separate compliance reports you have to reconcile yourself.
Actionable, prioritized reports
Findings prioritized by severity and business impact. Remediation steps specific, sequenced, and in plain language your entire team can act on.
Post-delivery support
Our team stays available after delivery. If your developers hit a wall during remediation, you’re not on your own.
Full premarket & postmarket support
We work with manufacturers at every stage — from pre-submission security assessment through ongoing postmarket cybersecurity obligations under FDA and MDR/IVDR.
68 projects delivered
A proven track record across 30+ industries — including healthcare, fintech, and compliance-heavy enterprise environments.
Device-risk-profile approach
Every engagement starts with understanding your device’s specific risk profile — not a generic checklist copied from the last engagement.
Plain language communication
No jargon, no inflated security theater. We communicate clearly so your whole team knows what was found, why it matters, and exactly what to do.
We Are Here for You at Any Stage of Your Device Life Cycle
Pre-market security assessment
Your device should enter the market with zero known vulnerabilities. We work with medical device and SaMD manufacturers to find and eliminate security gaps before submission — and deliver a complete risk mitigation roadmap.
Let’s Build This Together →Post-market security
assessment
Security doesn’t stop at FDA clearance. We assess already-registered devices to help manufacturers meet ongoing FDA and MDR/IVDR postmarket cybersecurity obligations — and help healthcare providers verify device safety and compliance.
Let’s Build This Together →Doubtful About Cybersecurity Assessment for Your Healthcare Device?
Let us dispel your concerns directly.
Yes, and that’s exactly why multi-regulation coverage is built into how we work. Our team maps every finding to the relevant regulatory frameworks so you’re not patching one requirement while accidentally creating a gap in another. You get one integrated view — not four separate compliance reports you have to reconcile yourself.
Every report we produce is written with your team in mind. Findings are prioritized by severity and business impact. Remediation steps are specific, sequenced, and explained in plain language. And our team stays available after delivery — so if your developers hit a wall during remediation, you’re not on your own.