Gap Assessment
Our experts review FDA observations and identify documentation gaps requiring prompt technical remediation.
FDA Response Services
FDA Cybersecurity
Deficiency Response Services
Get practical support to resolve FDA cybersecurity deficiencies with validated evidence and documentation that meets regulatory expectations.
2500+
Assessments Delivered
98%
Client Satisfaction
NDA
Protected
TRUSTED BY LEADING MEDTECH COMPANIES
Received an FDA
Cybersecurity Deficiency Letter?
An FDA cybersecurity deficiency letter means the agency needs additional evidence before completing its review. Common reasons include:
- Missing technical documentation
- Incomplete security testing
- Gaps in cybersecurity risk management
A clear and well-supported response helps address FDA observations efficiently.
Common FDA Cybersecurity Deficiencies
Incomplete threat model
Missing or incomplete SBOM
Inadequate cybersecurity risk assessment
Insufficient penetration testing evidence
Missing SPDF documentation
Poor traceability between risks and security controls
Incomplete security architecture documentation
Weak cybersecurity lifecycle processes
Our FDA Deficiency Response Services
Expert support to resolve cybersecurity deficiencies with validated evidence that aligns with current FDA expectations.
Our Deficiency Response Process
Qualysec guides you through every stage of the FDA deficiency response with technical precision and clarity.
01
Review FDA Letter
Our experts analyze every cybersecurity observation and supporting request.
02
Gap Analysis
Identify missing evidence against current FDA cybersecurity expectations.
03
Technical Assessment
Evaluate documentation security controls and supporting technical evidence.
04
Security Testing
Perform targeted testing to validate identified security gaps.
05
Internal Review
Cross-verify every response before regulatory submission.
06
Submission Support
Prepare complete response packages for FDA cybersecurity review.
What You Will Receive
Your response package includes the essential cybersecurity documents FDA expects during deficiency resolution and premarket review.
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?
Qualysec combines specialized penetration testing expertise with FDA cybersecurity knowledge to help you address deficiency letters effectively. Our team delivers thorough technical assessments, practical remediation guidance, and well-structured documentation that supports clear responses to FDA cybersecurity observations.
- FDA & Medical Device Security Experts
- Manual + Automated Testing Approach
- Fast Turnaround Without Compromising Quality
- Remediation Support Included
- Global Delivery Model with Flexible Engagements
06+
Years of Security Expertise
2500+
Assessments Completed
50+
Medical Devices Tested
100%
FDA Requirements Addressed
30 Days
Avg. Deficiency Response Turnaround
95%
Client Retention Rate
FAQ
Frequently Asked Questions
Find quick answers about FDA cybersecurity deficiency letters, response timelines, supported submission types, and what Qualysec delivers during the engagement.
It is a request from the FDA asking for additional information before it can continue reviewing your medical device submission.
Read each observation carefully, understand what is missing, and prepare a response that answers every point with supporting information.
The timeline depends on the complexity of the deficiencies. After reviewing your documents, we can estimate the required effort.
Each submission follows different regulatory requirements. We tailor the assessment and response to the pathway used for your device.
We usually start with the FDA letter, your submission package, cybersecurity documents, and any existing security testing results.
We review the new comments, identify unresolved issues, and help prepare another response with additional supporting information.
Contact us as early as possible. We assess the priority items first and focus on preparing the most critical response materials.
Yes. We support AI enabled devices by preparing cybersecurity documentation and reviewing PCCPs where applicable.
Depending on your needs, you may receive reports, updated security documents, traceability records, and an FDA response package.
Pricing depends on the number of deficiencies, required testing, available documentation, and the complexity of your device.
Ready to Resolve Your
FDA Cybersecurity Deficiency?
Talk to our experts today and get a tailored remediation plan for your organization.