When should we test the cloud environment?

Ideally, test before submission and after major changes. This helps catch security issues before they affect your regulatory evidence or product release.

Does SaMD need penetration testing?

Yes. Reviewers expect hands-on testing of the application, its interfaces, and the cloud services it depends on.

Does SaMD need a software bill of materials?

Yes. Section 524B expects an SBOM covering commercial, open-source, and off-the-shelf components, including libraries your build pulls in.

Can Medysec help if FDA asks for more cloud security evidence?

Yes. Medysec reviews the FDA request, checks your existing evidence, identifies gaps, and carries out additional testing or documentation where needed.

Does Medysec provide a retest after cloud vulnerabilities are fixed?

Yes. Medysec can retest reported findings after remediation and provide updated results showing whether the fixes address the original security issues.

SaMD Cybersecurity

FDA Cybersecurity for Software-as-a-Medical-Device Submissions

We help SaMD teams secure their software and build the evidence FDA expects, without treating it like a hardware device.

Talk To A Healthcare Cybersecurity Expert

Software as a medical device cybersecurity illustration

Built for Your Product

SaMD Solutions We Secure

Your software architecture determines your attack surface. We evaluate the security testing specifically to your application's architecture so that you get exactly what you need for FDA clearance.

Cloud-Based Clinical & Workflow Platforms
Healthcare platforms evaluated across IAM, cloud configuration, APIs, tenant isolation, and clinical data protection.
Mobile Diagnostic & Therapeutic Applications
Complete security testing for iOS and Android medical apps, covering code, storage, authentication, and backends.
Web-Based Medical Imaging & Clinical Applications
Testing web applications across authentication, APIs, session security, data handling, and application logic.
AI/ML-Enabled SaMD
We secure AI software, algorithms, and APIs against adversarial inputs, prompt risks, and data leaks.

What We Evaluate

SaMD Attack Surface We Assess

We analyze your application’s entire attack surface to identify hidden vulnerabilities, secure data flows, and build submission-ready regulatory evidence.

Web Applications & APIs
- Authentication, authorization, access control, API security, session management, input validation, business logic, data exposure, and security misconfigurations.
Mobile SaMD — iOS & Android
- Local storage, cryptography, certificate validation, authentication, secure communication, application tampering, runtime security, and mobile-to-backend API security.
Cloud Infrastructure & Security
- IAM roles, service accounts, privileged access, key management, cloud configurations, exposed services, storage, secrets.
SBOM, Dependencies & Third-Party Components
- SBOM review, vulnerable dependencies, outdated components, open-source libraries, SDKs, external APIs, and software supply-chain risks.

Our Process

Our SaMD Cybersecurity Process Workflow

We start with how the software operates, then scopes the analysis and testing around the product's risk and regulatory context.

01
SaMD Scope & Attack Surface Mapping
Define SaMD scope and map web, mobile, API, cloud, integrations, data flows, roles, and interfaces.
02
Architecture & Threat Modeling
Review architecture, trust boundaries, data flows, dependencies, communication paths, and controls to identify threats.
03
Cybersecurity Risk & Security Requirements Assessment
Assess assets, threats, vulnerabilities, risks, security requirements, controls, and residual risks with full traceability.

Standards & Framework

Standards and Frameworks We Follow

Our assessments use applicable medical-device, software-security, risk-management, and application-security references based on the product, market, and engagement scope.

FDA Cybersecurity in Medical Devices
FDA Postmarket Management of Cybersecurity in Medical Devices
FD&C Act Section 524B
Secure Product Development Framework (SPDF)
IEC 81001-5-1
ANSI/AAMI SW96:2023
ISO 14971:2019
OWASP Top 10:2025
OWASP Mobile Top 10:2024
OWASP MASVS
OWASP API Security Top 10:2023
OWASP ASVS

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

SaMD 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.

Read Case Study