CYBERSECURITY TESTING
FOR MEDICAL DEVICES
FOR MEDICAL DEVICES
Did you know that complying with FDA and MDR cyber requirements takes more than Penetration Testing?
That’s why we call it Cybersecurity Testing
That’s why we call it Cybersecurity Testing
WHAT WE TEST
While testing, we follow regulatory bodies, OWASP, NIST, CIS and ISO security testing guidelines
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Medical DevicesPenetration testing for Software as a Medical Device and Medical Devices that include Software -
Wearables & IoTPenetration testing for Wearable and IoT networked Medical Devices and threats validation -
Source CodeBinary, dependencies, and source code analysis for security breaches -
Cloud InfrastructureCloud infrastructure and backend security assessment -
Risk AssessmentCybersecurity risk assessment and Threat Modeling compliant with FDA, TGA and EU MDR requirements -
Tech Design & ControlsA gap assessment for your technical design and security controls
We accelerate your path to market by ensuring swift, cost-effective regulatory approval without cybersecurity headaches.
Our specialised cyber compliance expertise in FDA, TGA, and MDR regulations minimises the risk of rejection and potential redesigns, saving you time and money.
Our specialised cyber compliance expertise in FDA, TGA, and MDR regulations minimises the risk of rejection and potential redesigns, saving you time and money.
WE MAKE OUR CLIENTS HAPPY
WE MAKE OUR CLIENTS HAPPY
With us, you are confident that there are no security issues impeding the timely launch of your device to the market.
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Hight QualityWe are extremely detailed in the testing and document preparation, identifying and implementing improvements. We follow all the regulatory changes and updates -
Great SupportSubmission support from start to finish till the successful outcome. We answer your and the regulatory body questions any day of the week and any time of the day -
Fixed Prices and WarrantiesOur services come with fixed pricing, ensuring no surprises and complete transparency on what to expect. Plus, we guarantee delivery and quality -
Individual ApproachOur company works according to the principle of individual approach to every client. This method allows us to achieve success in problems of all levels
OUR APPROACH
This is how we guarantee a successful clearance
Requirements & Scoping
Gathering detailed requirements and reviewing existing documentation and the technical file to define the right scope of testing
Test Plan
Preparing a detailed and compliant Test Plan and designing the tailored Test Protocols specifically for your device to cover all the critical components
Testing
Executing the security testing according to the approved Test Plan and following the Test Protocols
Intermediate Reports
Preparing technical test reports with findings and mitigation recommendations. Presenting and explaining the report to your technical team
Retesting
Guiding your technical team through the discovered security issues and then retest to ensure all the threats were appropriately fixed
Final Reports
Preparing the final Test Summary Report and Cybersecurity Management Report with all the required details and traceability
RISKS OF NOT WORKING WITH US
RISKS OF NOT WORKING WITH US
We've helped quite a few devices - hiring our team will shield your business from these risks
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RejectionPotential rejection of your applications, resulting in resubmission and loss of valuable time - RedesignCyber requirements to redesign the software or even the hardware component of your device
- Incorrect ScopingMissing critical components in your testing scope or testing unnecessary items is non-compliant and inefficient
- Additional ExpensesIncomplete cybersecurity testing may overlook critical issues, leading to higher costs at later stages
Our team of certified and highly-skilled Penetration Testers, Information Security and Compliance professionals has completed several cybersecurity testing projects that have been successfully cleared by FDA, TGA and EU MDR regulatory authorities.
We're with you every step of the way – through successful clearance and post-market support
WE ARE IN BRISBANE AND MELBOURNE
contact@medsectesting.com
+61 434 732 731
FREE CONSULTATION contact@medsectesting.com
+61 434 732 731
OUR TEAM
We're located in Australia and deliver Worldwide
- Organising and leading the testing projects, designing the tech documentation, removing blockers and ensuring on-time deliveryDenisTest Manager [CISM, ISO13485, IEC62304, ISO27001, ISO9001, ISTQB]
- Alongside with Denis, preparing all technical documentation required for the successful completion ad coordinating the testingIrinaTest Analyst [ISTQB, ISO27001, CC]
- Hacking into the device to ensure adequate cyber security controls and practices are implementedValPenetration Tester [CISSP, CISA, CISM, GWAPT, GCIH]
- Simulating a hacker's attack to ensure the cyber security defence and effective threat monitoring are implementedArtPenetration Tester [CISSP, OSCP, GCPN]
- Observing the test execution and issues resolution to ensure the delivery is within the regulatory requirementsAlexRegulatory Advisor [ISO13485, MDSAP, MDR, MDD, ISO9001, ISO27001]
- Validating the technical design and cloud environment to ensure the configuration is secure and doesn't contain major issuesSergCloud Security Engineer and Architecture [AWS, Microsoft]
CONTACT US
contact@medsectesting.com
+61 434 732 731
+61 434 732 731
Our team is located in Brisbane and Melbourne, Australia
As per the FDA guidance on Cybersecurity in Medical Devices, penetration testing might be required as a component of your premarket submission procedure. Our team specialises in conducting Penetration Testing for a variety of devices, applications, and infrastructure. With your consent, we also conduct code reviews and reverse engineering on your software to ensure that it does not expose any critical information. This may also include testing your cloud and data storage configuration
