From implantable devices and patient monitors to remote diagnostics and therapy delivery systems - today’s medical technologies are increasingly connected. But connectivity brings new risks. Vulnerabilities in these systems can compromise patient safety, violate regulatory requirements, and damage brand trust.
At PCA Cyber Security, we help medical device manufacturers stay ahead of threats with in-depth penetration testing and security assessments designed specifically for connected medical products and embedded healthcare systems.
The Challenges of Medical Device Security
Securing connected medical devices means managing a growing attack surface, meeting evolving regulations, and supporting long product lifecycles. Key risks include patient harm from vulnerabilities in cyber-physical systems, delays in patching deployed devices, and exposure through wireless and physical interfaces. Cloud backends and mobile apps add further remote attack vectors.
All of this must be addressed while complying with strict frameworks like the FDA’s premarket guidance, EU MDR/IVDR, IEC 62304 and ISO 81001-5-1.
How can PCA Cyber Security help You?
PCA provides high-assurance security testing tailored to the real-world risks facing connected medical devices. We go beyond checklists to deliver advanced attack simulations across local, remote, and physical vectors, practical, engineering-ready remediation guidance, risk-driven prioritization based on likelihood, impact, and patient safety relevance.
Our team collaborates closely with your engineers, product managers, and security teams throughout the testing process to ensure findings are relevant and actionable.
Objective of the Service
Designed to uncover and validate vulnerabilities that could impact patient safety, device functionality, or clinical workflows. Simulates real-world attacks across physical, local, and remote vectors to assess product resilience and provide engineering-focused, regulation-aligned recommendations. Suitable for devices in development, premarket review, or production to support secure design validation and faster compliance approvals.
Business Benefits of Medical Device Penetration Testing
Risk Reduction &
Threat Mitigation
Real-world attack scenarios to identify and remediate vulnerabilities, reducing risks to both patients and healthcare providers.
Compliance with
Industry Standards
Support faster regulatory approval under frameworks like MDR, IVDR, and FDA.
Early Detection of
Critical Issues
Identify security flaws before market launch to avoid post-release problems.
Comprehensive Medical Device Security Testing
OUR TARGETS:
We work with medical device manufacturers, healthcare technology providers, and digital health startups across a wide range of devices and platforms, including:
- Wearable and implantable medical devices
- Vital sign monitors and infusion pumps
- Diagnostic and lab automation equipment
- Companion mobile/desktop apps and physician dashboards
- Telehealth and remote patient monitoring systems
- Embedded software, firmware, and proprietary hardware platforms
Our penetration testing evaluates hardware and software vulnerabilities, ensuring end-to-end security across IoT ecosystems.
Medical Device Penetration Testing Service Scope
Our assessments cover the entire attack surface of a connected medical device, including:
Our Methodology
In our engagements, we rely on proven best practices the PTES (Penetration Testing Execution Standard), OWASP Web Testing Guide, OWASP Mobile Testing Guide, OSSTM (The Open-Source Security Testing Methodology Manual) and others.
Our engagement typically includes the following phases:
Secure Your Medical Devices with Expert Penetration Testing!
Ensure your medical devices and connected healthcare systems are secure against cyber threats.
Contact PCA Cyber Security today to schedule a free consultation.
Client
and Partner Testimonials
We work with a wide range of companies across various industries, such as automotive, energy, financial services, and more.
"We can recommend PCA Cyber Security for their professional penetration testing service."
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Why PCA Cyber Security?
Your security is our mission - safeguarding your critical assets
Proven track record
- 100+ successful international cybersecurity assessment projects
- 50+ vulnerabilities found (2024)
- Uncovered critical vulnerabilities in top automotive brands
Team of Product Security Experts
- Advanced expertise in embedded penetration testing
- Exceptional in-house toolset and personnel (CyberLab, CyberGarage)
- Product-focused Threat Intelligence Platform (TICAP) and monitoring services
Professional Recognition
- TISAX ® (Trusted Information Security Assessment eXchange) accreditation
- Successful participants at Pwn2Own Automotive contest (Tokyo, January 2024 & 2025)
- Recognized speakers at Black Hat, Hexacon, Escar, Hacktivity and more