Expose cyber threat
FDA 510(k) Compliant Medical Devices Penetration Testing
Unable to comply with FDA 510(k) cybersecurity tests? Our 510(k) penetration testing exposes our weaknesses and provides submission-ready reports. Quick, precise, and adhering to the guidance of the FDA in June 2025.
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Definition
What is FDA 510(k) Compliance Penetration Testing?
Expose cyber threat
FDA 510(k) compliance penetration testing is performed to test the cybersecurity of your medical device before submission. It replicates real-life cyberattacks in order to unearth a vulnerability. The evidence generated through this FDA 510(k) cybersecurity testing is the evidence that FDA reviewers need under Section 524B.
Section 524B of the FD&C Act requires cybersecurity documentation on all cyber devices. FDA 510(k) medical device penetration tests should be able to provide reasonable assurance of safety. Failure to be properly tested results in Refuge to Accept (RTA) decisions.
The premarket penetration testing conducted by the FDA should be consistent with the cybersecurity guidance published in June 2025. The FDA 510(k) security testing of our medical device verifies firmware, software, and connectivity controls. The outcome is FDA-ready documentation that is trusted and accepted by the reviewers.
why it is essential?
Why FDA 510(k) Compliance is Essential for Your Medical Products?
Expose cyber threat
The FDA has now mandated cybersecurity evidence on any submissions of cyber devices provided under Section 524B. The RTA decisions and delays are the result of non-compliant FDA 510(k) penetration testing. The success of your product launch will rely on adequate penetration testing and documentation of the FDA 510 (k).
Key Points
- Legal Requirement Under Section 524B: FDA 510(k) testing of cybersecurity testing is required since March 2023 on cyber devices.
Prevent 60-90 Day Delays: FDA 510(k) medical device penetration testing is not done in its entirety, leading to a long review process.
- Reduce RTA Risk: Appropriate FDA premarket penetration testing eliminates Refuse to Accept.
- Protect Patient Safety: FDA 510(k) Medical device security testing determines the risks that may cause adverse effects on a patient.
- Demonstrate Reasonable Assurance: FDA 510k compliance penetration testing is an assurance that your device is safe and effective.
Enable Global Market Access: FDA-compliant testing helps to make EU MDR/IVDR and international submissions.
Why Must FDA SUBMISSION FAILS
How Qualysec Can Help You Achieve FDA 510(K) Compliance?
Generic penetration testing does not pass FDA 510(k) cybersecurity testing. This is why the majority of their reports are rejected, and how Qualysec addresses these issues.
Reason for Rejection
How Qualysec Fixes It
Reason for Rejection & How Qualysec Fixes It
Tool-Driven, Generic Pen Testing
An automated scan will give generic results, without exploit validation. This is weak evidence in the FDA 510(k) penetration testing that is reviewed by the FDA.
Manual, FDA-Focused Pen Testing
Qualysec is a blend of automation and manual exploitation to conduct 510(k) medical device penetration testing by the FDA. We show actual risk and realistic attack paths.
No Link to Patient Safety or Intended Use
Results are not mapped to patient harm or clinical workflow. Your FDA 510(k) cybersecurity testing report cannot be assessed by the FDA.
Patient-Safety-Centric Risk Analysis
Every discovery is related to patient safety and intended application. FDA risk assessment is supported by our FDA 510 (k) security testing of medical devices.
Reports Not FDA-Submission Ready
Reports are not traceable to FDA guidance, threat models and SBOM. This brings RTAs into compliant penetration testing of the FDA in 510k reviews.
FDA-Ready Documentation & Evidence
Qualysec provides submission-ready reports that are consistent with June 2025 FDA premarket penetration testing guidance.
Fast-Track Your FDA Journey
Get a FDA Test Quote Now
A Complete Road Map for Guaranteed Success
Our rigorous testing methodology aligns with industry best practices and FDA guidance, including the Pre-Market and Post-Market Cybersecurity Guidelines.
Swagat Kumar Dash
Business Development Manager
“Connect with Swagat, Your trusted penetration testing advisor. Secure your assets. Reach out Today!”
WHY CHOOSE US?
Why Choose Qualysec for FDA 510(k) Compliance Penetration Testing?
Qualysec delivers FDA-aligned penetration testing with deep medical-device expertise, helping you identify real security risks, meet regulatory expectations, and submit with confidence—faster and without surprises.
FDA-Ready Reports
Our FDA 510(k) penetration testing reports would satisfy the June 2025 guidance precisely. Submission- no amendments necessary after FDA inspection
Manual Testing Where It Matters
We extend automated scanners to manual exploitation. Cybersecurity testing in the Deep FDA 510(k) reveals the vulnerabilities that are not detected by tools.
Unlimited Retests Until You Pass
Remediation has no limit on verification. We perform all fixes by extensive FDA 510(k) medical device penetration testing.
Patient Safety Drives Everything We Do
Each finding is mapped onto patient harm potential and clinical impact. Our premarket penetration testing, according to FDA reviewers, prioritises the risks of interest to our FDA reviewers.
Built for Global Regulatory Success
Our medical device FDA 510(k) medical device security testing is focused on FDA, EU MDR and IEC 62443. A single test allows numerous submissions in the market.
Fixed-Fee Pricing, No Surprises
There are no surprises in the transparent pricing of the FDA 510k penetration testing of the entire engagement of compliance. No back-of-book expenses or change orders.
our compliance standards
MedTech Industry Compliance Standards We Follow
ISO 14971 • FDA Guidance • AAMI TIR57 • NIST 800-115 • ISO 13485 • AAMI TIR97 • ISO 27001
and others…..
other compliance we provide
Other Compliances That can Fulfill by Our Pentest Report
Testimonials
Words of Satisfaction from Our Valued Clients
Read what our clients say about our services. See how Qualysec has helped several businesses to keep their digital assets safe!
Very prompt with service and replies.Qualysec Technologies was incredibly prompt in both their service delivery and their replies. I was impressed by their efficiency and professionalism. Highly recommended
Rishi Verma
Our experience with Qualysec was excellent. The thoroughness of testing, the quick response time and their team’s availability to brainstorm any queries feedback made the entire process as smooth as possible
Mike Perry
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
The team delivered clear, concise reports, categorized by severity levels of vulnerabilities. Each report included detailed technical insights and executive summaries for all stakeholders.
Mitul Pansuriya
Qualysec delivered a seamless experience with excellent project management and clear communication. The team was responsive, met deadlines, adapted well, and offered great post-delivery support.
Billy Sadhu Sharma Kumar
The most impressive qualities of this company were their exceptional communication and the robust, detailed reports they generated, and providing thorough guidance on necessary remediations.
Jordan Rothstein
Everything went as planned, with deliveries always on time. The team was smooth to work with, and their speed of execution stood out, making the whole process efficient and seamless.
Manuel Agustin Napoli
The team demonstrated exceptional professionalism with their consistently short response times and strict adherence to the project schedule. Their professionalism was impressive.
Andreas Schriefl
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.
Pragnesh Chauhan
I was impressed by the level of detail put into the reporting was very detailed, including what steps were done to produce the issue and what we needed to do to remedy the issue. Everything was very well detailed and impressive.
Thomas Jones
The team was highly professional and consistently met all deadlines. They went above and beyond by expanding the project scope to address unexpected issues—despite having no obligation to do so. A truly dependable and great team to work with.
Chad Galgay
Our experience with Qualysec was excellent. The thoroughness of testing, the quick response time and their team’s availability to brainstorm any queries / feedback made the entire process as smooth as possible.
Jazel Oommen Verma
Our experience with Qualysec was very positive. They offer excellent service, communicated clearly with us throughout the process, and were very accommodating regarding our timelines.
Mike Perry
Qualysec Technologies was incredibly prompt in both their service delivery and their replies. I was impressed by their efficiency and professionalism. Highly recommended.
Rishi Verma
Process
Our FDA 510(k) Penetration Testing Process Simplifies FDA Clearance
We follow a structured, FDA-aligned testing approach that identifies critical vulnerabilities, validates security controls, and produces clear, audit-ready reports—making your 510(k) clearance smoother and faster.
Let Qualysec help you find gaps in your security & suggest fixes to protect your digital assets.
Free Downloads
Download Our Free Resources and Reports
Access expert insights, compliance guides, and in-depth security reports to help you strengthen your cybersecurity posture and stay ahead of regulatory requirements.
FDA 510(k) Penetration Testing Checklist
Complete checklist covering all FDA 510(k) cybersecurity testing requirements per June 2025 guidance.
FDA Section 524B Documentation Guide
Guide to all 11 essential documents for FDA 510(k) medical device penetration testing submission.
FDA Medical Device Threat Modelling Template
Step-by-step threat modelling process aligned with AAMI TIR57 and FDA premarket penetration testing.
Get a quote
Schedule a Consultation for FDA 510(k) Compliance Pentesting!
Book a free initial consultation to discuss your medical device's specific needs and how our FDA 510(k) compliance penetration testing can help secure FDA approval. We share a personalized quote based on your device's complexity and testing needs.
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FAQ
Frequently Asked Questions
Get quick answers to common questions about API security testing, its benefits, frequency, costs, and more.
What is FDA 510(k) compliance?
FDA 510(k) compliance refers to the process by which medical device manufacturers demonstrate that their product is as safe and effective as a legally marketed device, to gain approval for U.S. market entry.
What is FDA 510(k) compliance penetration testing?
It is the process of identifying cybersecurity vulnerabilities in a medical device to ensure its safe operation and compliance with FDA requirements.
Is penetration testing mandatory for FDA 510(k) compliance?
The FDA strongly encourages manufacturers to include cybersecurity assessments, such as penetration testing, to meet premarket submission guidelines.
What is the purpose of FDA 510(k) submission?
The purpose is to prove that a medical device is significantly comparable to one already on the market, giving confidence to the authorities about its safety and effectiveness before it is sold in the U.S.
When should penetration testing be conducted for FDA 510(k) compliance?
Penetration testing should be conducted during the device’s development phase, before submission, and periodically post-market to identify potential vulnerabilities.
What are the key areas assessed in FDA 510(k) penetration testing?
Key areas include device application, network connectivity, data encryption, access controls, and the ability to handle unauthorized access attempts.
