Threat Modeling
Identify potential attack paths early to strengthen security architecture and reduce risks before software deployment.
FDA SaMD Services
SaMD Cybersecurity
Services
Protect your Software as a Medical Device with expert cybersecurity testing that helps you identify risks before they affect patients or compliance.
Crest Accredited
ISO 27001 Certified
FDA Guidance Aligned
TRUSTED BY LEADING MEDTECH COMPANIES
DEFINITION
What is Software as a Medical Device (SaMD) Cybersecurity?
Software as a Medical Device cybersecurity is the process of securing standalone medical software throughout its lifecycle
Software as a Medical Device cybersecurity is the process of securing standalone medical software throughout its lifecycle. It involves identifying security weaknesses, validating controls, and protecting clinical applications against threats that could affect patient safety, data integrity, or the availability of essential medical functions.
Our SaMD Cybersecurity Services
Explore focused security services built around the architecture, clinical purpose, and regulatory needs of your SaMD product.
Medical Device Software Penetration Testing
Uncover exploitable vulnerabilities through comprehensive testing that validates the security of your medical software environment.
API & Backend Security Testing
Assess APIs and backend services for vulnerabilities that could expose sensitive data or disrupt clinical functionality.
SBOM Review & Validation
Review software components to identify vulnerable dependencies and improve supply chain security across your application.
Security Risk Assessment
Evaluate cybersecurity risks, prioritize remediation, and connect technical findings with potential clinical and business impact.
Cloud & Infrastructure Security Assessment
Assess cloud environments and infrastructure configurations to reduce security gaps affecting your medical software platform.
Secure Development Lifecycle (SDLC) Review
Review development practices to strengthen secure coding, testing, deployment, and vulnerability management throughout the software lifecycle.
Remediation Validation & Compliance Support
Verify implemented fixes and provide evidence that supports regulatory submissions and cybersecurity compliance activities.
Industry Standards & Frameworks We Follow
FDA 2026 Guidance
NIST SP 800-53
NIST SP 800-160
ISO 14971
IEC 81001-5-1
IEC 62443
ISO 13485
Our Process for SaMD Services
Our Process for SaMD Cybersecurity Assessments
Our assessment follows a structured process that helps you uncover risks, strengthen security, and support regulatory expectations confidently.
01
Learn How Your SaMD Works
We review the intended use, clinical role, users, architecture, and technology supporting the software.
02
Set the Assessment Boundaries
Together, we decide which applications, APIs, cloud services, integrations, and environments need to be examined.
03
Map Data Flows and Attack Paths
Our team studies how information moves through the system and where an attacker could interfere.
04
Test the Complete Environment
Testing covers the software, backend services, access controls, cloud setup, and other connected components within scope.
05
Confirm What Is Exploitable
Each issue is checked manually so your report includes genuine weaknesses rather than unverified scanner results.
06
Explain the Risk Clearly
We show how every finding could affect your product, clinical functions, patient data, or service availability.
07
Support Your Remediation Work
Your developers receive clear steps, practical guidance, and direct support while addressing the reported security issues.
08
Retest and Finalize the Evidence
Once fixes are complete, we test them again and document the results for your internal and regulatory needs.
Testimonials
What Our Clients Say About Us
Read what our clients say about our services. See how Qualysec has helped several businesses to keep their digital assets safe!
“
Qualysec did a great job identifying vulnerabilities in our web and cloud applications and gave us clear steps to fix them. They stuck to deadlines, handled re-tests, and supported well.
Kenny Kim
Product Manager
How Qualysec Stacks Up
A transparent comparison of our approach versus building in-house or hiring a typical vendor.
Capability
Qualysec
In-House Team
Typical Vendor
FDA Guidance Expertise
100% aligned
Requires training
Often limited
Threat Modeling
Included
Depends on resources
Partial
Penetration Testing
Comprehensive
Requires multiple tools
Partial
SBOM Review & Validation
Included
May lack expertise
Often limited
Remediation Support
Included
Internal effort
Frequently charged separately
Documentation Support
Included
Internal effort
Partial
Common FDA Premarket Cybersecurity Challenges We Solve
Unclear FDA Guidance Interpretation
Complex Device Architecture
Legacy System Risks
Third-Party & Open Source Risks
Documentation Gaps for Submission
Get a Quote
Secure Your Mediacl Devices. Stay FDA Compliant
One overlooked weakness inside an AI agent can expose sensitive data, misuse connected systems, or disrupt important workflows. Qualysec helps you uncover those risks through focused security testing built for modern AI environments. Give your team clearer visibility into how your AI agents behave before attackers get the chance to test them first.
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Total No. Of Vulnerabilities
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Years in Business
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Assessment Completed
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Trusted Clients
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Countries Served
FAQ
Frequently Asked Questions
Find clear answers about SaMD cybersecurity testing, FDA expectations, cloud-based products, deliverables, and lifecycle support.
Software as a Medical Device is standalone software that performs medical functions such as diagnosis, monitoring, or treatment without forming part of a physical medical device.
The FDA expects cybersecurity evidence based on product risk. Security testing, including penetration testing, helps demonstrate that appropriate cybersecurity controls have been verified.
It depends on your product. If it meets the Section 524B criteria, including software authorization and internet connectivity, it may qualify as a cyber device.
Our assessment may include application, API, cloud, infrastructure, authentication, authorization, configuration, and penetration testing based on your product architecture and scope.
Yes. Qualysec can assess your application, APIs, cloud infrastructure, and connected components to identify security weaknesses across the complete deployment environment.
You receive a detailed report with validated findings, risk ratings, technical evidence, remediation guidance, and a retest report after verified issue resolution.
The timeline depends on your application's complexity, architecture, and testing scope. Most assessments are completed within a few weeks after project kickoff.
Yes. Qualysec supports cybersecurity activities aligned with FDA premarket documentation and ongoing postmarket vulnerability management throughout the product lifecycle.
Yes. Third-party AI services introduce additional cybersecurity considerations that should be assessed and documented as part of your product's overall security posture.
Pricing depends on your SaMD architecture, deployment environment, testing scope, and compliance needs. Contact Qualysec for a tailored project estimate.