Can Medysec assess whether our current cybersecurity evidence is sufficient before FDA submission?

Medysec reviews existing architecture, threat models, SBOMs, testing, risk assessments, and traceability to identify evidence gaps before the package reaches FDA review.

Do we need a full SBOM before work starts?

No. We can build or validate the SBOM as part of the engagement, including third-party and open-source components.

How does Medysec handle cybersecurity findings that cannot be fully remediated before submission?

Medysec evaluates residual risk, documents compensating controls and rationale, updates relevant assessments, and determines whether additional testing or evidence is necessary.

How long does it take to build the package?

Scope decides it. Most engagements run in stage order, and we give a fixed timeline in the plan before work begins.

What if the FDA questions the link between our cybersecurity testing and risk assessment?

Medysec can trace findings from testing through vulnerabilities, threats, controls, residual risks, remediation, and retesting to create consistent evidence across the submission package.

FDA Premarket Cybersecurity

Cybersecurity Services for FDA Premarket 510(k), De Novo, PMA

We help medical device teams turn 510(k), De Novo, and PMA cybersecurity requirements into clear, submission-ready evidence.

Book a Briefing

FDA premarket cybersecurity services illustration

What Premarket Covers

The Documentation that FDA Expects in a Premarket Cybersecurity Package

The premarket package is defined by FDA guidance and Section 524B. We deliver 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

Our FDA Premarket Cybersecurity Process Workflow

Every artifact starts from the same source, which is your device. We map data flows, score risk, build the SBOM and test the interfaces before writing a word.

01
Discovery, Scope & Regulatory Assessment
Assess device scope, architecture, FDA pathway, cybersecurity objectives, timelines, and applicable requirements.
02
Architecture & Attack Surface Assessment
Review device architecture, software, interfaces, data flows, dependencies, trust boundaries, and attack surfaces.
03
Threat Modeling & Cybersecurity Risk Assessment
Identify threats, vulnerabilities, attack paths, impacts, controls, and residual cybersecurity risks.

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.

Standards & Framework

Standards and Frameworks We Follow

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

FDA 2026 Guidance
ISO 14971
Section 524B
AAMI SW96
AAMI TIR57
AAMI TIR97
IEC 81001-5-1
IEC 62443-4-1
IEC 62304
ISO 13485
ISO 27001
NIST 800-115
UL 2900
MDCG 2019-16

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 Section 524B FAQ

Frequently Asked Questions

A threat model, SBOM, security risk assessment, architecture views, penetration test evidence, cybersecurity labelling, and a postmarket vulnerability management plan.