Cyber Security for Medical Devices and Software as a Medical Device
FREE CONSULTATION

CYBERSECURITY TESTING
FOR MEDICAL DEVICES

Actually, more than Cybersecurity and Penetration Testing for Medical Devices - we understand both Cybersecurity and Regulatory Requirements
FREE CONSULTATION

WHAT WE TEST

While testing, we follow regulatory bodies, OWASP, CIS and ISO security testing guidelines
  • Medical Device penetration testing

    Medical Devices

    Penetration testing for Software as a Medical Device and Medical Devices that include Software
  • IOT and Software as a Medical Device penetration testing

    Wearables & IoT

    Penetration testing for Wearable and IoT networked Medical Devices and threats validation
  • Source Code vulnerabilities analysis

    Source Code

    Binary, dependencies, and source code analysis for security breaches
  • Cloud architecture AWS, Azure or Google and API assessment

    Cloud Infrastructure

    Cloud infrastructure and backend security assessment
  • Cybersecurity risk analysis and documentation

    Risk Assessment

    Cyber security risk assessment compliant with FDA, TGA and EU MDR requirements
  • Cybesecurity validation for your solution technical design to ensure there are no security gaps or possible vulnurabilities

    Tech Design

    A gap assessment for your technical design and dataflows
We accelerate your path to market by ensuring swift, cost-effective regulatory approval without cybersecurity headaches.

Our specialised 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

With us, you are confident that there are no security issues impeding the timely launch of your device to the market.
  • We produce high quality results

    Hight Quality

    We are extremely detailed in the testing and document preparation, identifying and implementing improvements. We follow all the regulatory changes and updates
  • We provide amazing support

    Great Support

    Submission 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
  • Our prices are very competitive

    Fixed Prices and Warranties

    Our services come with fixed pricing, ensuring no surprises and complete transparency on what to expect. Plus, we guarantee delivery and quality
  • We plan testing individually for each client.

    Individual Approach

    Our 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 delivery
1
Requirements
Gathering detailed requirements via meeting the core team, existing documentation, and follow-up emails
2
Test Plan
Preparing a detailed and compliant Test Plan and designing the most effective Test Protocols specifically for your device
3
Testing
Executing the security testing according to the approved Test Plan and following the Test Protocols
4
Initial Report
Preparing technical test reports with findings and mitigation recommendations. Presenting and explaining the report to your technical team
5
Retesting
Guiding your technical team through the discovered security issues and then retest to ensure all the threats were appropriately fixed
6
Final Report
Preparing the final Test Summary Report with all the required details including test methods, any issues left, their priorities and risk level



RISKS OF NOT WORKING WITH US

Hiring our team in the early stages will shield your business from these risks
  • We produce high quality results

    Rejection

    Potential rejection of your applications, resulting in resubmission and loss of valuable time
  • We produce high quality results

    Redesign

    You may be required to redesign the software or even the hardware component of your device
  • We produce high quality results

    Incorrect Scoping

    Missing critical components in your testing scope or testing unnecessary items is non-compliant and inefficient
  • We produce high quality results

    Reputation Damage

    Incomplete cybersecurity testing may overlook critical issues, leading to higher costs for fixes later in your device's lifecycle
Our team of certified and highly-skilled Penetration Testers and Information Security and Compliance professionals has completed various cybersecurity testing projects that have been successfully approved by FDA, TGA and EU MDR regulatory authorities.
None of the devices we tested have been rejected by the regulatory body because of security issues
WE ARE IN BRISBANE AND MELBOURNE

contact@medsectesting.com
+61 434 732 731
FREE CONSULTATION
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 delivery
    Denis
    Test Manager [ISTQB, ISO13485, IEC62304, ISO9001, ISO27001]
  • Alongside with Denis, preparing all technical documentation required for the successful completion ad coordinating the testing
    Irina
    Test Analyst [ISTQB, ISO27001]
  • Hacking into the device to ensure adequate cyber security controls and practices are implemented
    Val
    Penetration Tester [CISSP, CISA, CISM, GWAPT,GCIH]
  • Simulating a hacker's attack to ensure the cyber security defence and effective threat monitoring are implemented
    Art
    Penetration Tester [CISSP, CCSP, CCIE Security, PCNSE, NSE4]
  • Observing the test execution and issues resolution to ensure the delivery is within the regulatory requirements
    Alex
    Regulatory 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 issues
    Bianco
    Cloud Security Engineer and Architecture [AWS, Microsoft]
CONTACT US
contact@medsectesting.com
+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
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