Medical Device Penetration Testing
Our Medical Device Penetration Testing service helps medical device manufacturers and healthcare providers assess and strengthen the cyber resilience of connected medical technologies. We identify vulnerabilities, validate security controls, and support compliance with Medical Device Regulation (EU) 2017/745, In Vitro Diagnostic Regulation (EU) 2017/746, ISO/IEC 81001-5-1, and the MDCG 2019-16 Rev.1 Guidance on Cybersecurity.
Why Medical Device Penetration Testing?
Detect cybersecurity weaknesses in connected medical devices and health IT systems
Fulfill expectations from MDR/IVDR Annex I (General Safety & Performance Requirements)
Align with MDCG cybersecurity guidance, IMDRF, and FDA expectations
Reduce risk of patient harm, data breaches, and regulatory noncompliance
Demonstrate due diligence under the MDCG 2019-16 Rev.1 Guidance on Cybersecurity
Devices & Systems We Test
Medical imaging systems (MRI, CT, ultrasound)
Remote monitoring and wearable devices
Implantable device interfaces
Laboratory and diagnostic devices (IVD software)
Surgical robots and infusion pumps
Mobile health apps and cloud-based platforms
Hospital network-connected devices (HL7/DICOM/FHIR)
Get Started Today
Strengthen the cyber security and compliance posture of your medical devices. Contact us today to schedule introduction call. Our team is committed to ensuring a reliable and secure medical device experience for your patients.