Can Medysec review my existing cybersecurity package before I submit it to the FDA?

Yes. Medysec reviews your architecture, cybersecurity evidence, and required artifacts to identify gaps before the package reaches FDA reviewers.

What happens to cybersecurity responsibilities after my connected medical device receives FDA clearance?

Postmarket activities continue through vulnerability monitoring, intake and triage, risk assessment, remediation, security updates, validation, disclosure, and ongoing documentation.

Can one cybersecurity package cover both the medical device and its supporting software?

The package can address the connected product ecosystem, with evidence covering applicable device software, applications, cloud components, interfaces, risks, and security controls.

What if my device uses a third-party or open-source component with a known vulnerability?

The component can be assessed for exploitability, affected versions, attack paths, device impact, mitigations, patches, and compensating controls.

Can Medysec help when FDA asks for additional cybersecurity evidence during review?

Yes. Medysec can analyse the request, identify evidence gaps, update affected artifacts, perform required testing, and prepare supporting technical response content.

FDA Cybersecurity Compliance

FDA Cybersecurity Compliance Framework for Connected MedTech

We help manufacturers turn Section 524B's requirements into documented evidence that satisfies FDA reviewers.

Talk to a MedTech Security Expert

Medysec Deliverables

What FDA Cybersecurity Deliverables Does Medysec Provide

From threat modeling and SBOM to penetration testing and postmarket planning, Medysec helps teams address the security work behind Section 524B.

1
Cybersecurity Risk Management
2
Threat Modeling
3
Cybersecurity Risk Assessment
4
Software Bill of Materials (SBOM)
5
Software Level of Support & End-of-Support
6
Safety & Security Assessment of Vulnerabilities
7
Cybersecurity Assessment of Unresolved Anomalies
8
Cybersecurity Controls
9
Security Architecture
10
Cybersecurity Metrics
11
Cybersecurity Risk Management Plan
12
Cybersecurity Labeling
13
Penetration Testing Report
14
Penetration Retesting Report

Our Compliance Process

Our FDA 510(k) Cybersecurity Compliance Process Workflow

We connect product architecture, cybersecurity risk, testing, documentation, and postmarket planning so your submission reads as one complete security story.

01
Discovery, Scope & Regulatory Assessment
Assess the device, FDA pathway, cybersecurity scope, objectives, timelines, and applicable requirements.
02
Architecture & Attack Surface Assessment
Review device architecture, software, firmware, APIs, cloud, networks, wireless interfaces, and attack surfaces.
03
Threat Modeling & Cybersecurity Risk Assessment
Identify assets, threats, vulnerabilities, attack paths, impacts, controls, and residual cybersecurity risks.

Standards & Framework

Standards and Frameworks We Follow

Our FDA cybersecurity work is informed by the standards and frameworks relevant to your product and submission.

FDA Cybersecurity in Medical Devices
FDA Postmarket Management of Cybersecurity in Medical Devices
FD&C Act Section 524B
FDA Content of Premarket Submissions for Device Software Functions
FDA Off-The-Shelf Software Use in Medical Devices
FDA Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
ISO 14971:2019
ANSI/AAMI SW96:2023
AAMI TIR57
IEC 81001-5-1:2021
IEC 62304
IEC 62443 Series

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 are 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

FDA Cybersecurity Case Studies

Cybersecurity Evidence for Connected Devices

Explore Case Studies

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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Healthcare platform threat-modeling case study illustration

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

Patient-facing health application cloud security case study illustration

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 Study

FDA Cybersecurity FAQ

Frequently Asked Questions

Yes. Changes can affect the threat model, SBOM, risk assessment, testing scope, architecture, and other cybersecurity artifacts supporting the submission.