Is penetration testing required for a submission?

FDA guidance expects security testing of the device and its interfaces, and reviewers look for evidence that testing was actually performed.

Do we need to test the production firmware?

Testing the release candidate or production-equivalent firmware gives more useful evidence because it reflects the software that will actually reach customers.

How does Medysec handle medical devices with limited test access?

Medysec adjusts the approach around available access, using permitted interfaces, firmware analysis, documentation, and other evidence to assess meaningful attack paths.

Can Medysec test vulnerabilities across the device and cloud together?

Yes. Medysec can follow a vulnerability across the device, APIs, cloud services, and connected applications to understand whether it creates a broader attack path.

Can testing evidence be reused across markets?

Often, yes. One well-scoped test can support FDA and EU evidence when the build and risk profile are unchanged.

MedTech Penetration Testing

Penetration Testing for Medical Devices

We provide hands-on penetration testing across medical devices, applications, APIs, and cloud environments, with scope built around the product and its real attack surface.

Scope a Penetration Test View Testing Capabilities

Healthcare penetration testing illustration

Penetration Testing Services

Penetration Testing for Every Connected Layers

From the medical device itself to the applications and cloud services around it, Medysec tests the connected attack surface that supports modern healthcare technology.

Medical Device Penetration Testing
Hardware teardown, firmware, cloud API, white-box methodology. FDA-ready report with signed LOA.
Explore Medical Device Pentesting
Application Penetration Testing
Healthcare web app, mobile companion app, EHR integration. OWASP ASVS L2/L3, NIST SP 800-53, manual + automated blend.
Explore Application Pentesting
Cloud Penetration Testing
Assessment of cloud infrastructure, identity, APIs, storage, and device-to-cloud paths.
Explore Cloud Pentesting

Our Process

Our Penetration Testing Process Workflow

We define the scope, understand the product, test meaningful attack paths, validate findings, and document what needs to change.

01
Scope & Attack Surface Mapping
Map devices, firmware, applications, APIs, cloud, networks, wireless interfaces, and connected services.
02
Architecture & Threat Analysis
Review architecture, data flows, trust boundaries, dependencies, exposed services, and controls to identify attack paths.
03
Automated & Manual Security Testing
Conduct automated and expert led manual testing across devices, applications, APIs, cloud, networks, and wireless systems.

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 no prior knowledge to test your device, applications, APIs, cloud infrastructure, and security controls from the outside.
Grey Box Testing
Combines external attack simulation with authorized access like API specs, documentation, and test accounts to provide deeper, more effective security coverage.
White Box Testing
Analyzes source code, firmware, architecture, SBOMs, and cloud configurations to deliver comprehensive vulnerability testing and validation.

Standards & Framework

Standards and Frameworks We Follow

Our premarket work considers applicable FDA guidance, cybersecurity standards, vulnerability practices, and risk management requirements relevant to the device and its market.

FDA Cybersecurity in Medical Devices — February 2026
ANSI/AAMI SW96:2023
ISO 14971:2019
AAMI TIR57
IEC 81001-5-1:2021
IEC 62304
MDCG 2019-16 Rev.1

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.

01
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.
02
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.
03
Internal Reviewer Simulation
Two named Medysec experts review the package against FDA 2026 guidance check-by-check before handoff. Findings flagged, retested, and closed.
04
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

Penetration Testing Success Stories

Discuss Your Environment

Diagnostic desktop application cybersecurity case study illustration

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 clientâ€™s FDA 510(k) documentation.

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