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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.
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.
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.
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.
We work with medical device manufacturers, healthcare technology providers, and digital health startups across a wide range of devices and platforms, including:
Our penetration testing evaluates hardware and software vulnerabilities, ensuring end-to-end security across IoT ecosystems.
Our assessments cover the entire attack surface of a connected medical device, including:
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.
We work with a wide range of companies across various industries, such as automotive, energy, financial services, and more.
Your security is our mission - safeguarding your critical assets
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.
"We can recommend PCA Cyber Security for their professional penetration testing service."
Proven track record
Team of Product Security Experts
Professional Recognition