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Discovery & Artifact Plan
Our senior Medysec expert reads device architecture, intended use, regulatory pathway, and existing cybersecurity evidence then delivers a written artifact plan and fixed-fee quote inside 5 business days.
Medical Device Penetration Testing
Medical Device Penetration Testing with FDA-Ready Reporting
Hands-on penetration testing of medical device hardware, firmware, wireless interfaces, and companion applications, identifying exploitable vulnerabilities before FDA reviewers or attackers do.
Medical Device Attack surface
What We Test Across Your Medical Device
We assess the technical layers that make up the product, from physical interfaces and firmware to wireless, applications, and cloud.
Hardware & Physical Interfaces
Firmware & Embedded Software
Authentication & Authorization
Wireless & Communication Interfaces
Data Protection & Cryptography
Software & Third-Party Components
Our Process
Our Medical Device Penetration Testing Process Workflow
We begin with the device and its architecture, then test the interfaces and components that define its security boundary.
MedTech segments
Device Categories We Test
We test across the categories that carry connected software, from monitoring and diagnostics to therapy delivery and software-only products.
Patient Monitoring & Vital Signs Devices
Cardiovascular Monitoring & Diagnostic Devices
Diabetes & Continuous Glucose Monitoring
Infusion & Drug Delivery Systems
Remote Patient Monitoring & Connected Wearables
Respiratory Monitoring & Therapy Devices
Diagnostic Imaging & Ultrasound Systems
Ophthalmic Diagnostic & Monitoring Devices
Electrodiagnostic & Neurodiagnostic Devices
General Hospital & Connected Medical Equipment
Penetration Testing Types
Testing That Goes Beyond the Device Surface
We choose the testing approach according to the product, available access, technical evidence, risks, and assessment objective.
Black Box Testing
Simulates an external attacker with limited or no prior knowledge of the device's internal architecture, source code, firmware, hardware design, and security implementation.
Grey Box Testing
Combines external attack simulation with authorised internal information, such as test accounts, device documentation, firmware details, network information, or limited architecture and configuration details.
White Box Testing
Analyzes internal assets like code, firmware, architecture, and SBOMs to enable deeper vulnerability discovery and complete validation.
Standards & Framework
Standards and Frameworks We Follow
Our assessments use applicable standards and frameworks relevant to medical device cybersecurity and penetration testing.
- ISO 14971:2019
- ANSI/AAMI SW96:2023
- AAMI TIR57
- IEC 81001-5-1:2021
- IEC 62304
- IEC 62443 Series
- IEEE 11073-40101
- IEEE 11073-40102
- MDCG 2019-16
- FDA Cybersecurity in Medical Devices
- FDA Postmarket Management of Cybersecurity in Medical Devices
- FD&C Act Section 524B NIST Cybersecurity Framework (CSF)
- NIST Secure Software Development Framework (SSDF)
Step-by-Step Workflow
How to Begin Securing Your MedTech Cybersecurity with Medysec
We analyze your device architecture, build complete cybersecurity evidence, and hand your team an audit-ready submission package.
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Authoring & Testing
Medysec runs hands-on threat modeling, SBOM authoring, security risk assessment, and penetration testing on the named device, using the agreed artifact plan as the work contract.
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Internal Reviewer Simulation
Two named Medysec experts review the package against FDA 2026 guidance check-by-check before handoff. Findings flagged, retested, and closed.
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Submission Hand-off
You get a one-hour walk-through with your regulatory lead, a Letter of Attestation, and a fixed-fee retest commitment if FDA raises cybersecurity deficiencies.
In Their Words
What Our Clients Say
We work alongside device manufacturers to secure their connected medical devices and clear regulatory review. Here is what those teams have to say about us.
Qualysec Technologies Pvt Ltd's efforts resulted in improved security, risk mitigation, enhanced security controls, and compliance achievement. The team was responsive, flexible, and open to addressing the client's evolving needs. They maintained regular communication via email and virtual meetings.
Billy Sadhu Sharma Kumar
Head-V&V Engineering
Case Studies
Medical Device Penetration Testing Success Stories
An European MedTech Startup Secures Its Diagnostic Desktop App With Medysec Ahead of FDA 510(k) Submission
A security assessment of a diagnostic desktop application used with the TearView platform, focused on protecting patient diagnostic data, strengthening application controls, and supporting the client’s FDA 510(k) documentation.
Read Case Study
Building a practical threat-modeling process for a healthcare platform
A healthcare platform engagement that clarified security ownership, mapped critical attack paths, and improved evidence for release decisions.
Read Case Study
Securing cloud services behind a patient-facing health application
A practical cloud security review that helped a patient-facing product prioritise its most important configuration and access-control improvements.
Read Case StudyMedical Device Pentesting FAQ
Frequently Asked Questions
For hardware and firmware work, yes. Where a device cannot travel, we scope the test to reachable interfaces and software layers.
Ready to Run a Medical Device Penetration Test?
Tell us what you are working on and we will give you a straight read on scope, timeline, and cost.