Threat Modeling
Our experts map attack paths, trust boundaries, and risks across your complete medical device ecosystem.
FDA Premarket Services
FDA Premarket
Cybersecurity Services
Protect your medical device with Qualysec's FDA premarket cybersecurity services, from risk assessment and testing to submission-ready evidence.
Crest Accredited
ISO 27001 Certified
FDA Guidance Aligned
TRUSTED BY LEADING MEDTECH COMPANIES
DEFINITION
What is FDA Premarket Cybersecurity Testing?
FDA premarket cybersecurity testing is the process of assessing a medical device and its connected systems.
FDA premarket cybersecurity testing is the process of assessing a medical device and its connected systems to identify cybersecurity risks before submission to the FDA. It verifies that security controls work as intended, evaluates potential threats, and generates evidence that supports the device's safety, effectiveness, and regulatory review.
Our FDA Premarket Cybersecurity Services
Qualysec provides complete cybersecurity support to prepare your medical device and technical evidence for FDA premarket submission.
SBOM Review & Validation
Qualysec reviews software components, validates dependencies, and prepares accurate SBOMs for FDA submission support requirements.
Medical Device Penetration Testing
Using realistic attack scenarios, our team uncovers exploitable weaknesses across devices, firmware, applications, and infrastructure.
Cybersecurity Risk Assessment
Our assessment connects cybersecurity risks with patient impact and documents residual risk using structured methodologies.
Cloud & API Security Testing
Qualysec examines cloud environments and APIs for misconfigurations, access flaws, and sensitive data exposure risks.
Wireless & Communication Protocol Assessment
Through protocol-focused testing, we uncover weaknesses in wireless interfaces that may affect connected devices.
Secure Documentation Support
Our specialists prepare cybersecurity evidence, traceability records, and supporting documents for your FDA premarket submission.
Remediation Validation & Retesting
After remediation, Qualysec retests affected components and confirms whether identified vulnerabilities have been resolved effectively.
Industry Standards & Frameworks We Follow
FDA 2023 Guidance
NIST SP 800-53
NIST SP 800-160
ISO 14971
IEC 81001-5-1
IEC 62443
ISO 13485
Our Process for FDA Premarket
Cybersecurity Assessments
Every assessment follows a structured workflow that strengthens your medical device security while supporting FDA premarket cybersecurity expectations.
01
Project Kickoff & Scope Definition
The engagement begins by defining assessment boundaries, identifying connected assets, confirming objectives, and reviewing applicable FDA cybersecurity requirements.
02
Architecture Review & Threat Modeling
Next, our security specialists examine your system architecture, establish trust boundaries, and map realistic attack scenarios across the device ecosystem.
03
Security Risk Assessment & SBOM Validation
Building on identified threats, Qualysec evaluates cybersecurity risks, validates software components, and reviews dependencies for regulatory readiness.
04
Comprehensive Penetration Testing
Real-world attack techniques are applied to assess firmware, applications, APIs, cloud services, and connected device components for exploitable weaknesses.
05
Communication Protocol & Infrastructure Testing
Every communication channel, supporting infrastructure, and wireless interface is examined to uncover security gaps that scanners often overlook.
06
Vulnerability Analysis & Remediation Guidance
Each confirmed finding is investigated, prioritized by business and patient impact, then accompanied by practical recommendations for effective remediation.
07
Remediation Validation & Retesting
Once your team completes the fixes, targeted retesting verifies that vulnerabilities have been addressed without introducing additional security concerns.
08
FDA Ready Reporting & Documentation
The final stage delivers submission-ready reports, traceability records, and supporting cybersecurity evidence aligned with current FDA expectations.
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
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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 FDA premarket cybersecurity submission types, testing scope, deliverables, timelines, and remediation support.
Qualysec supports cybersecurity assessments for 510(k), De Novo, PMA, PMA supplements, HDE, and other FDA premarket submission pathways requiring security evidence.
Connected medical devices, Software as a Medical Device, wearable devices, diagnostic systems, and products with software or network connectivity commonly require a cybersecurity assessment.
Yes. Qualysec provides penetration testing, threat modeling, security risk assessment, SBOM validation, and supporting documentation as part of the engagement.
You receive technical reports, remediation guidance, retest results, risk assessment records, and supporting documentation tailored to your project requirements.
Timelines vary with device complexity, system scope, and testing requirements. After reviewing your project, we provide a realistic delivery schedule.
Yes. Our team reviews the identified gaps, performs additional assessments when needed, and helps strengthen supporting cybersecurity documentation.
Qualysec combines manual testing, regulatory understanding, and practical remediation support to deliver findings that engineering teams can confidently address.
Pricing depends on your device architecture, testing scope, submission requirements, and project complexity. Contact Qualysec for a customized quotation.