FDA-Compliant Penetration Testing with QualySec
Protect your medical devices and healthcare systems against vulnerabilities. With our expert FDA-focused penetration testing, achieve compliance while strengthening your security posture.
4+
Years in Business
600+
Assessment Completed
150+
Trusted Clients
21+
Countries Served
What is FDA 510(k) Compliance?
FDA 510(k) compliance is a premarket submission process required by the U.S. Food and Drug Administration (FDA) to ensure that medical devices meet safety and effectiveness standards. This applies to most Class II and some Class I and III medical devices before they can be sold in the United States. To receive approval, manufacturers demonstrate that their device is either substantially equivalent to an already approved device or introduces no new safety or performance concerns.
What is FDA 510(k) Pentesting?
FDA 510(k) penetration testing is a specialized cybersecurity assessment for medical devices seeking FDA approval. It involves simulating real-world cyberattacks to identify vulnerabilities in device software, firmware, and communication systems to achieve compliance as per FDA cybersecurity guidelines. Qualysec has a proven track record of providing exceptional penetration testing and compliance services to companies worldwide. Our FDA 510(k) Pentesting ensures your medical devices are secure, compliant, and market-ready.
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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!
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
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
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.
Founding Engineer
The team demonstrated exceptional professionalism with their consistently short response times and strict adherence to the project schedule. Their professionalism was impressive.
Medical Device Software Company
They follow industry standards for testing the web and cloud applications to ensure they look perfect.
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
Their professionalism, technical expertise, and willingness to expand scope without extensive costs were iTheir professionalism, technical expertise, and willingness to expand scope without extensive costs were impressive.
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
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
Types of FDA 510(k) Penetration Testings We Perform
Our versatile testing capabilities make sure that all aspects of your device's security are covered. We customize solutions for every type of medical device technology, including:
We begin by engaging with your team to understand your specific security concerns, business objectives, and the scope of the test.
Our experts define the boundaries and objectives of the penetration test and ensure clarity on the systems, applications, and environments to be tested.
We carefully plan the testing process, selecting the most appropriate tools, methodologies, and techniques to simulate realistic attack scenarios.
Our skilled testers execute the penetration tests by simulating ethical attacks to identify vulnerabilities and assess their potential impact on your systems.
We run complete network security tests, focusing on everything from firewalls to communication protocols. This helps your device’s network to stay safe from potential attacks and fully compliant with FDA security standards.
How It Works
Qualysec FDA 510(k) Compliance Pentesting Process
At Qualysec, we follow a streamlined, 3-stage thorough process to make sure your device meets stringent FDA standards with confidence.
Stage 1
Pre-Assessment Planning
QualySec understands device functionality and documents existing cybersecurity measures.We build a customized testing strategy aligned with FDA cybersecurity guidelines.
Stage 2
Comprehensive Penetration Testing
We conduct vulnerability scans and simulate real-world attacks to identify security gaps by testing features like network connectivity, access controls, and software updates.
Stage 3
Results Analysis and Reporting
Our team snalyzes test results and provide a detailed report outlining risks and remediation actions. We support in preparing the necessary cybersecurity documentation for 510(k) submission.
Key Benefits
Why Choose Qualysec for FDA 510(k) Pentesting?
Qualysec can be a valuable partner in achieving FDA 510(k) Compliance for medical devices. With our expertise, we offer comprehensive services tailored to meet the strict requirements of the FDA 510(k) process. Our team makes sure that your healthcare device meets necessary safety and security standards before market submission.
FDA 510(k) Compliance Pentesting
FDA 510(k) Compliance Penetration Testing is a cybersecurity assessment for medical devices seeking market approval. It involves simulating cyberattacks to identify vulnerabilities in device software, firmware, and communication systems.
Complete Risk Identification
We go beyond basic security checks to identify hidden vulnerabilities and fully protect your app or device against a wide range of cyber threats.
Customized Testing for FDA Requirements
Our expert team customizes penetration testing strategies to align with FDA-specific cybersecurity guidelines without compromising on product performance or security.
Thorough Vulnerability Assessments
We evaluate every crucial element of your medical device - from software to communication systems - leaving no stone unturned.
Expert Regulatory Guidance
Our team brings years of expertise in interpreting and implementing FDA cybersecurity guidelines specific to the 510(k) submission process.
Comprehensive Reporting & Documentation
Receive detailed reports complete with risk assessments, remediation strategies, and submission-ready documentation for the FDA.
Ongoing Compliance Monitoring
We don't stop after testing. Our continuous monitoring ensures your device remains secure and compliant throughout its lifecycle.
Secure Your Systems and Stay FDA-Compliant
Don’t leave cybersecurity to chance. Choose our FDA-focused penetration testing now!
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Start Your FDA Compliance Journey Today!
Want to be sure about the security and success of your medical device? Fill in the form and we will get back to you with our custom FDA 510(k) Compliance Pentesting services.
4+
Years in Business
600+
Assessment Completed
150+
Trusted Clients
21+
Countries Served
FAQ
Frequently Asked Questions
Get quick answers to common questions about API security testing, its benefits, frequency, costs, and more.
What is the purpose of FDA 510(k) Penetration Testing?
FDA 510(k) penetration testing ensures that your medical devices are protected from cyber threats and meet the FDA’s cybersecurity requirements, safeguarding sensitive patient data and maintaining the integrity of your devices..
Is penetration testing mandatory for compliance?
The FDA strongly encourages manufacturers to conduct cybersecurity assessments, including penetration testing, to meet premarket submission guidelines.
When should penetration testing be conducted?
Testing should take place during the device’s development phase, before submission, and periodically post-market to ensure continued security.
What vulnerabilities are assessed during FDA 510(k) pentesting?
Key areas include device software, network connectivity, data encryption, access controls, and resilience to unauthorized access.
How does Qualysec simplify the 510(k) compliance process?
Qualysec provides expert guidance, detailed testing, risk management strategies, and comprehensive documentation support to ensure compliance and market readiness.
What documentation will I receive after pentesting?
You’ll receive a detailed report that includes findings, risk assessments, vulnerability descriptions, and actionable recommendations, which can be used to support your FDA 510(k) submission and compliance efforts
