Product Cybersecurity Consultation for Medical Devices

Submission-ready security for MedTech startups & OEMs

Product cybersecurity consultation for medical devices from L4B Software helps MedTech startups and OEMs design, document, and prove device security. We deliver SBOM/VEX, threat modeling, vulnerability management, and secure OTA with verification evidence—aligned to FDA §524B and EU MDR. This product cybersecurity consultation for medical devices reduces recall risk and accelerates submissions while protecting developer velocity.

Our specialists translate standards (IEC 62304, ISO 14971, UL 2900, IEC 62443) into practical controls, pipelines, and evidence that slot straight into your DHF/Technical File.

Why L4B Software?

Regulatory-grade engineering: Deep expertise in embedded/OS (also with MediTUX OS), secure boot & OTA, and evidence creation for safety-critical devices.
Reviewer-friendly deliverables: Threat model, SBOM/VEX, vulnerability management, secure update concept, and verification records – written the way auditors and hospitals expect.
Lightweight for developers: We wire the process into your CI/CD and supplier flows, so security supports velocity instead of blocking it.

Who this is for?

Startups (Seed – Series C) preparing first 510(k), De Novo, or PMA for connected devices.
Established OEMs needing portfolio-wide §524B/MDR consistency, supplier hardening, and recall-risk reduction.

Engagement Options

Startup §524B Readiness Sprint

Outcome: a submission-ready security package for your device.

Submission appendix mapping to FDA §524B and EU MDR GSPR
Threat model + integrated security risk file (ISO 14971 alignment)
SBOM (SPDX 2.3) per build + VEX; vuln intake/triage workflow
Cybersecurity Plan, disclosure policy, secure update/OTA concept
Verification strategy & example records (SAST/DAST/SCA, pen-test summaries)

OEM Security Program Accelerator

Outcome: consistent, scalable cybersecurity across your portfolio.

SDL policies and supplier clauses (IEC 62443 / UL 2900 aligned)
Central SBOM/VEX & vulnerability management with roles, SLAs, evidence trail
Post-market surveillance and recall-prevention playbook tied to CAPA/PSUR
Internal audit dry-run + Notified Body / FDA support materials

Verification & Validation (Add-On or Standalone)

Outcome: objective, defensible test evidence.

SAST/DAST/SCA pipeline definition + hands-on setup for your stack (C/C++, containers, images)
Pen-testing scope, execution partners coordination, findings to remediation with retest proof
Traceability from requirements → controls → tests → residual risk

Strengthen Your Product Cybersecurity Now

Align your device with FDA, EU MDR, and NIST expectations, including SBOM, vulnerability triage, and secure update strategy.

Process overview

Our product cybersecurity consultation for medical devices runs through six stages. Each stage produces concrete artifacts, requirements, SBOM/VEX, test evidence, and policies—that slot directly into your DHF/Technical File. The flow ensures every control is backed by traceable evidence and mapped to the clauses reviewers expect, reducing questions, audit friction, and recall risk.

Compliance & Evidence Mapping

Requirement	What we implement/provide	Benefit / Value for the customer
FDA §524B (SBOM, monitoring, updates)	SBOM+VEX, vulnerability intake/triage, signed update concept, disclosure policy	Faster, cleaner submissions (fewer review questions), reduced recall/liability risk, and easier hospital procurement through SBOM/VEX & disclosure readiness.
EU MDR (state-of-the-art security, PMS/PSUR)	Security GSPR cross-references; PMS hooks for vulnerabilities & patches	Lower audit friction and continuous compliance; fewer nonconformities and stronger post-market credibility.
IEC 62304 (SOUP, traceability)	Tooling evidence, risk links, verification records for software of unknown provenance	Predictable releases and less rework via solid traceability; shorter audits with right-sized evidence per class A/B/C.
ISO 14971 (risk)	Cybersecurity risk file integrated with clinical risk	Defensible safety story tying security to patient risk → fewer clinical objections and clearer go/no-go decisions.
UL 2900 / IEC 62443 (as applicable)	Baselines, test evidence, supplier controls	Objective assurance for buyers, stronger supplier posture, and reduced incident likelihood—improves win rates in HDO security reviews.

Outcomes & business impact

Submission confidence: cybersecurity sections that pass internal QA and external review.
Operational resilience: faster response to CVEs, structured patching, and fewer field issues.
Sales enablement: MDS2/SBOM/VEX on hand for hospital security questionnaires.
Scalability: reusable templates and pipelines across product lines.
Developer throughput: security evidence created with minimal disruption.

FAQs

Do you cover 510(k), De Novo, and PMA?

Yes. We align artifacts and language to your regulatory pathway; cybersecurity expectations apply across all three.

Can you work with our existing toolchain?

Absolutely. We plug into your build/CI and can configure open-source or commercial SAST/DAST/SCA based on your policy and budget.

Do you provide pen-testing?

We design the scope and collaborate with qualified partners (or your preferred vendor). Findings are mapped to CWE/controls with retest proof and traceability.

How do you handle suppliers and SOUP?

We add SBOM & security clauses to supplier agreements, and create SOUP justifications with verification evidence per IEC 62304.

What about post-market obligations?

You’ll receive a vulnerability disclosure policy, monitoring workflow, and a patch/update strategy integrated with CAPA and PSUR/PMCF where applicable.

Ready for a Product Cybersecurity Consultation

Book a short session with our specialists to review your risk posture, compliance gaps, and a practical remediation plan.

Schedule My 30 Minute Consultation