When does a vulnerability require an FDA submission?

When the change affects the device's security or safety profile in a way that meets FDA reporting or supplement thresholds.

How do we check a security update before release?

Test the update for security issues and unexpected changes, then retest known vulnerabilities to make sure the fix works without introducing new risks.

Can Medysec help us investigate a new vulnerability?

Yes. Medysec can check whether the vulnerability affects your device, assess the risk, and help your team decide what action to take.

Can Medysec support our PSIRT team?

Yes. Medysec can support vulnerability investigation, technical analysis, remediation planning, retesting, and the security evidence your PSIRT process needs.

Can Medysec help when our device changes after testing?

Yes. Medysec can review the changes, check their security impact, and identify whether existing risk assessments, testing, or cybersecurity evidence needs updating.

FDA Postmarket Cybersecurity

FDA Postmarket Cybersecurity for Medical Devices

Once a device is cleared, the security work changes shape. We help manufacturers monitor, patch, and report on connected devices already in the field, so security doesn't stop at clearance.

Discuss Postmarket Security

FDA postmarket cybersecurity services illustration

Attack Surface

What Our Postmarket Cybersecurity Covers

FDA guidance and Section 524B set out what a postmarket programme must produce. This is the work we run for cleared devices.

Continuous Vulnerability Monitoring
CVE Triage & Severity Classification
Patch & Update Management
SBOM and VEX Maintenance
Managing Cybersecurity Documentation
Penetration Testing

Our Process

Our FDA Postmarket Cybersecurity Process Workflow

We establish monitoring, agree what counts as a critical finding, evaluate what arrives, support remediation, and keep the records your quality team has to file accurate and current.

01
Postmarket Cybersecurity Planning & Monitoring
Monitor CVEs, CISA KEV, vendor advisories, researchers, threat intelligence, and vulnerability disclosures.
02
Vulnerability Intake, Triage & Risk Assessment
Assess vulnerabilities based on exploitability, attack vectors, device impact, security impact, and patient safety.
03
Investigation & Remediation
Investigate root causes, affected versions, attack paths, and implement appropriate remediation or compensating controls.

Standards & Framework

Standards and Frameworks We Follow

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

FDA Premarket Cybersecurity Guidance (Feb 3, 2026)
FDA Postmarket Management of Cybersecurity in Medical Devices
FD&C Act Section 524B
ANSI/AAMI SW96:2023
ISO 14971:2019
AAMI TIR57
IEC 81001-5-1
IEC 62304

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

Postmarket Cybersecurity Success Stories

View All 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.

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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.

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FDA Postmarket Cybersecurity FAQ

Frequently Asked Questions

A defined process for receiving, assessing, and publishing vulnerability information, so researchers and customers know how to raise and track issues.