Can Medysec review my existing cybersecurity package before I submit it to 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 Services

FDA Cybersecurity for Connected Medical Devices

We support applicable medical device cybersecurity activities across premarket preparation, FDA deficiency letter response, SaMD security, and postmarket risk management.

Talk to a Medysec Expert Explore the FDA Cybersecurity Lifecycle

FDA Cybersecurity Services

Medical Device Cybersecurity Across the FDA Lifecycle

FDA cybersecurity reaches product design, risk management, software, testing, documentation, submission, and postmarket responsibilities. Medysec helps keep those activities connected.

Premarket Cybersecurity Services
Threat modeling, SBOM, risk assessment, and test evidence prepared for 510(k), De Novo, and PMA.
Explore Premarket Cybersecurity
FDA Cybersecurity Deficiency Response Services
Direct help closing an FDA cybersecurity deficiency letter with the evidence reviewers asked for.
Explore Deficiency Response
SaMD Cybersecurity Services
Security assessment and documentation for software as a medical device, including cloud and AI-enabled products.
Explore SaMD Cybersecurity
FDA Postmarket Cybersecurity Services
Monitoring, triage, and patch support for connected devices after clearance.
Explore Postmarket Cybersecurity

FDA Submission Pathways

Understanding How Medical Device Cybersecurity Changes by FDA Pathway

Cybersecurity requirements can differ by device, regulatory pathway, product architecture, and submission context. We have curated this list so as to identify where your security work fits.

Feature	510(k) Pathway	De Novo Pathway	PMA Pathway	IDE / Pre-submission
Documentation depth	Moderate	Moderate-high	High	Light
Reviewer scrutiny	Standard	Heightened	Heightened	Discussion only
Typical timeline	6–14 weeks	8–18 weeks	12–24 weeks	4–8 weeks
Best used for	Substantially equivalent predicate devices	Novel devices without predicate	High-risk Class III devices	Pre-submission feedback to FDA
Section 524B required	Yes (post-March 29, 2023)	Yes	Yes	Optional but recommended

FDA Cybersecurity Documentation

The Documentation FDA Expects in a Cybersecurity Package

This documentation is defined by FDA guidance and Section 524B. Medysec delivers each document in the format reviewers and your quality system both expect.

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

Our Process

How We Navigate Your FDA Cybersecurity

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

01
Postmarket Cybersecurity Planning & Monitoring
Monitor CVEs, NVD, CISA KEV, vendor advisories, researchers, and emerging threat intelligence.
02
Vulnerability Intake, Triage & Risk Assessment
Assess affected components, exploitability, attack paths, device impact, and patient safety risks.
03
Investigation & Remediation
Identify root causes, affected versions, attack paths, mitigations, patches, and compensating controls.

Standards & Framework

Standards and Frameworks We Follow

Medysec maps the engagement to the guidance, standards, and submission tools that are actually relevant to the device.

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 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 FAQ

Frequently Asked Questions

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