Gap Assessment
We review the FDA letter and identify all gaps and expectations.
FDA Response Services
FDA Cybersecurity
Deficiency Response Services
Respond to FDA cybersecurity deficiency letters with confidence. We help you remediate gaps, strengthen security, and submit complete, compliant documentation faster.
2500+
Assessments Delivered
98%
Client Satisfaction
NDA
Protected
Deficiency Letter
Signature
FDA
TRUSTED BY LEADING MEDTECH COMPANIES
Responding to FDA
Deficiency Letters Can Be
Complex and Time-Sensitive
FDA issues deficiency letters when cybersecurity risks, documentation gaps, or testing evidence do not meet regulatory expectations.
- Delays can impact product approval and market access
- Incomplete response can lead to repeated deficiencies
- Tight timelines and strict documentation requirements
Common FDA Cybersecurity Deficiencies
Incomplete Threat Model
Missing or Incomplete SBOM
Inadequate Risk Assessment
Inefficient Penetration Testing
Missing SPDF Documentation
Poor Traceability & Design Rationale
Inadequate Security Architecture
Lack of Cybersecurity Processes
Our FDA Deficiency Response Services
End-to-end support to remediate gaps and build a strong, submission-ready response.
Threat Modeling
We create or update threat models aligned with FDA guidance.
Security Risk Assessment
We assess and document security risks with evidence and mitigation.
Penetration Testing
We perform VAPT across web, mobile, API, network, cloud & devices.
SBOM Development
We generate accurate SBOM (CycloneDX / SPDX) with component mapping.
SPDF Documentation
We prepare complete SPDF documentation and test evidence.
FDA Submission Support
We help compile, review and submit response with confidence.
Our Deficiency Response Process
A proven, step-by-step approach to resolve deficiencies efficiently and effectively.
01
Review FDA Letter
We analyze the letter and extract all observations.
02
Gap Analysis
We map gaps against FDA guidance and requirements.
03
Technical Assessment
We assess architecture, security controls and documentation.
04
Security Testing
We perform VAPT and collect necessary evidence.
05
Internal Review
We review everything for accuracy and completeness.
06
Submission Support
We support you in submitting a strong, compliant response.
What You Will Receive
Comprehensive deliverables aligned with FDA expectations.
FDA Deficiency Response Report
Detailed response to each FDA observation.
Penetration Test Report
Complete VAPT report with findings and evidence.
Executive Summary
High-level summary for reviewers and leadership.
Threat Model
Updated threat model (STRIDE / TARA).
SBOM (CycloneDX / SPDX)
Software Bill of Materials with component details.
Risk Assessment
Documented risks with rating and mitigation.
Traceability Matrix
Linking requirements, design and test evidence.
SPDF Documentation
Complete SPDF package and templates.
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
Why Choose Qualysec?
We combine deep cybersecurity expertise with regulatory knowledge to deliver faster, better, and audit-ready outcomes.
- FDA & Medical Device Security Experts
- Manual + Automated Testing Approach
- Fast Turnaround Without Compromising Quality
- Remediation Support Included
- Global Delivery Model with Flexible Engagements
10+
Years of Security Expertise
2500+
Assessments Completed
120+
Vulnerabilities Identified (Avg.)
100%
FDA Requirements Addressed
45 Days
Avg. Deficiency Response Turnaround
95%
Client Retention Rate
Ready to Resolve Your
FDA Cybersecurity Deficiency?
Talk to our experts today and get a tailored remediation plan for your organization.