Continuous Vulnerability Monitoring
Continuously monitor emerging vulnerabilities affecting your released devices, software components, and supporting technology environments.
FDA Postmarket Services
FDA Postmarket
Cybersecurity Services
Keep your marketed medical devices resilient against evolving cyber threats with expert testing and ongoing security support.
Crest Accredited
ISO 27001 Certified
FDA Guidance Aligned
TRUSTED BY LEADING MEDTECH COMPANIES
DEFINITION
What are FDA Postmarket Cybersecurity Services?
FDA postmarket cybersecurity services help you identify, assess, and address cybersecurity risks after your medical device enters the market.
FDA postmarket cybersecurity services help you identify, assess, and address cybersecurity risks after your medical device enters the market. These services include vulnerability monitoring, security testing, patch validation, incident response, and technical documentation to support ongoing security, patient safety, and regulatory expectations throughout the product lifecycle.
Our FDA Postmarket Cybersecurity Services
Expert cybersecurity services that help you monitor, assess, secure, and maintain released medical devices throughout their operational lifecycle.
Postmarket Penetration Testing
Evaluate released products after updates, integrations, or infrastructure changes to uncover exploitable security weaknesses.
Coordinated Vulnerability Disclosure (CVD)
Establish structured disclosure processes for receiving, validating, managing, and responding to reported security vulnerabilities.
Security Patch Validation
Verify security patches resolve identified vulnerabilities without affecting functionality, performance, or essential device operations.
SBOM Monitoring & Management
Track software components, identify affected dependencies, and monitor newly disclosed vulnerabilities across released product versions.
Security Risk Reassessment
Reassess cybersecurity risks whenever vulnerabilities, software updates, or environmental changes affect released medical devices.
Incident Response & Remediation Support
Support technical investigations, containment activities, remediation planning, and recovery following confirmed cybersecurity incidents.
Compliance Reporting & Documentation
Prepare technical documentation supporting cybersecurity decisions, remediation evidence, and postmarket regulatory reporting requirements.
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 FDA Postmarket
Our Process for FDA Postmarket Cybersecurity Assessments
Below are the eight steps our team follows during every FDA postmarket cybersecurity assessment engagement.
01
Device Inventory & Scope Definition
We first confirm the released devices, software versions, connected services, and environments included in your postmarket cybersecurity assessment scope review.
02
Security Baseline Assessment
Our team reviews your current security controls and working procedures to find gaps before detailed testing begins across systems today.
03
Continuous Vulnerability Monitoring
We compare new vulnerability alerts with your product components and check whether any released version may be affected in use.
04
Postmarket Penetration Testing
Our testers assess the marketed product and connected systems to confirm which weaknesses can be exploited in real conditions safely.
05
Risk Analysis & Prioritization
Each finding is reviewed for technical impact, patient safety concerns, current safeguards, and the urgency of remediation across products deployed.
06
Remediation & Patch Validation
We test proposed fixes and temporary controls to ensure they reduce the identified risk without affecting essential device performance during deployment.
07
Retesting & Continuous Verification
After your team applies the fix, we test the product again and confirm the original weakness has been resolved properly.
08
Compliance Reporting & Ongoing Support
You receive clear technical reports, retest evidence, remediation guidance, and continued support for your internal regulatory review process and decisions.
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 postmarket cybersecurity monitoring, testing, patch validation, incident response, and regulatory support.
Yes. Manufacturers are expected to monitor released devices for emerging threats and address vulnerabilities that could affect safety or essential performance.
It involves tracking vulnerability alerts and supplier updates. Security complaints, SBOM components, threat intelligence, and signs of exploitation also require regular review.
Assessment frequency depends on device risk and product changes. Testing should also follow major updates, infrastructure changes, incidents, or relevant vulnerability disclosures.
A confirmed vulnerability can trigger patch validation. It may also follow a supplier update, security incident, product change, or revised compensating control.
Qualysec confirms whether the issue affects your product. We then test its exploitability and provide practical recommendations for fixing or reducing the risk.
Yes. Our experts help establish reporting channels and triage procedures. We also support researcher communication and maintain clear records for every disclosure.
Yes. Qualysec provides premarket security assessments and supports postmarket monitoring, penetration testing, patch validation, incident response, and cybersecurity documentation.
Deliverables may include technical findings and exploit evidence. You also receive remediation guidance, patch verification results, risk observations, and documentation for regulatory review.
Pricing varies with device complexity and assessment scope. The number of released versions, monitoring frequency, testing depth, and support period also affect cost.
Our team investigates the affected product and confirms the technical impact. We support containment, remediation, fix validation, and evidence preparation for internal review.