🎄✨ Season’s Greetings from MedSec Testing! ✨🎄 As 2024 comes to a close, we want to take a moment to thank our clients, partners, and community for your continued trust and collaboration. This year has been full of challenges and achievements, and we’re grateful to have been a part of your journey toward securing medical devices for a safer future. To celebrate the season, we’re offering a special opportunity: Secure your testing today and lock in discounted pricing for all of next year! Don’t miss this chance to plan ahead and start 2025 with peace of mind. Contact us before the year ends to take advantage of this exclusive offer! Wishing you a joyful Christmas, a refreshing New Year, and a holiday season filled with happiness and success. 🎁✨ Here’s to a secure and prosperous 2025! Warm regards, The MST Team #Cybersecurity #MedicalDevices #HappyHolidays #NewYear2025 #MedSecTesting
MedSecTesting
Computer and Network Security
South Brisbane, Queensland 438 followers
Cybersecurity testing for Medical Devices - For your FDA, TGA and EU MDR submission
About us
CYBERSECURITY TESTING FOR MEDICAL DEVICES • Penetration testing for Software as a Medical Device and Medical Devices that include Software. • Penetration testing for Wearable and IoT Medical Devices. • Binary, dependencies, and source code analysis for security breaches. • Cloud infrastructure and backend security assessment. • Cybersecurity risk assessment compliant with FDA, TGA and EU MDR requirements. While testing, we follow regulatory bodies, OWASP, CIS and ISO security testing guidelines. Our team is certified Penetration Testers and Information Security professionals. We provide all the required documentation related to cybersecurity for your pre/post-market submission. We have completed numerous cybersecurity testing projects that have been successfully approved by FDA, TGA and EU MDR regulatory authorities. With us, you will be confident that there are no blocking security issues for your device to get on the market. Our approach: 1. Initial meeting to discuss high-level requirements. 2. Signing Non-disclosure (NDA) and Intellectual property (IP) agreements. 3. Gathering detailed requirements via: a. Meeting the core team, b. Existing documentation, c. Follow-up emails. 4. Preparing a detailed and compliant Test Plan. 5. Designing the most effective test cases for your device. 6. Executing the security testing according to the approved Test Plan. 7. Preparing technical test reports with findings and mitigation recommendations. 8. We assist your technical team addresses the issues according to the recommendations. 9. Our test team re-test the failed modules and prepare the final report
- Website
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https://medsectesting.com/
External link for MedSecTesting
- Industry
- Computer and Network Security
- Company size
- 2-10 employees
- Headquarters
- South Brisbane, Queensland
- Type
- Privately Held
- Founded
- 2021
- Specialties
- Regulatory and compliance , Cybersecurity Testing, Cybersecurity, TGA, FDA, MDR, and IEC62304
Locations
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Primary
28 Merivale St
South Brisbane, Queensland 4101, AU
Employees at MedSecTesting
Updates
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MedSecTesting reposted this
Distributed Denial of Service (DDoS) attacks can disrupt device functionality, jeopardizing patient safety and healthcare operations. To build DDoS-resilient software, developers should adopt principles like minimizing attack surfaces, implementing secure protocols, and enabling redundancy. Leveraging cloud-based DDoS protection, real-time monitoring, and secure APIs further enhances resilience. Compliance with standards such as FDA, MDR guidance and ISO/IEC 27001 ensures regulatory alignment. Testing, including simulated DDoS scenarios, and collaboration with cloud providers and healthcare facilities are critical. Prioritizing cybersecurity ensures trust and reliability in medical devices. #MedicalDeviceCybersecurity #DDoSProtection #HealthcareIoTSecurity #CyberResilience #SecureSoftwareDevelopment #IoTDeviceSecurity #CloudSecurity #FDACompliance #CybersecurityStandards #PatientSafety #PenetrationTesting #APIProtection #NetworkSecurity #HealthcareInnovation #DDoSResilience
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The cybersecurity of medical devices plays a pivotal role in safeguarding patient safety, ensuring compliance with regulatory standards, and maintaining operational efficiency in today’s interconnected healthcare environments. With the rise of connected medical devices, these systems face unprecedented exposure to cyber threats. Strengthening cybersecurity requires a comprehensive approach that addresses four key areas: Resiliency, Availability, Hardening, and Recovery. ▶ Resiliency ensures that devices can withstand and recover from adverse events, such as cyberattacks or system failures, without disrupting critical functions. ▶ Availability guarantees that devices and their data are accessible when needed, minimizing downtime and ensuring continuity in patient care. ▶ Hardening involves fortifying devices by reducing vulnerabilities and limiting potential attack surfaces, creating a robust line of defence against threats. ▶ Recovery focuses on rapid restoration of functionality and data integrity, ensuring that systems can bounce back quickly with minimal impact after an incident. By embedding these principles into the design and operation of medical devices, manufacturers can proactively mitigate risks, enhance trust, and deliver secure, reliable solutions that meet the demands of modern healthcare. #Cybersecurity #MedicalDevices #HealthcareSecurity #Resiliency #SystemAvailability #SystemHardening #DisasterRecovery #PatientSafety #MedicalDeviceSecurity #ConnectedDevices #CyberResilience #DataProtection #RiskManagement #HealthcareIT #CyberThreats
The Role of Resiliency, Availability, Hardening, and Recovery in Cybersecurity for Medical Devices
MedSecTesting on LinkedIn
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Are you defining the scope of cybersecurity testing for your medical device and wondering what level of coverage is appropriate? Our latest article breaks down the essentials, helping you align your testing efforts with your device's risk profile and the applicable risk management concept. #RiskManagement #Cybersecurity #AFAP #ALARP #SFAIRP #MedicalDevices #CybersecurityTesting #HealthcareCybersecurity #Compliance #VulnerabilityManagement
Understanding AFAP, ALARP, and SFAIRP in Cybersecurity Testing for Medical Devices
MedSecTesting on LinkedIn
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High-level details you need to know about IEC 81001-5-1 by the Johner Institute are in the attached article. In short, this standard addresses IT security throughout the software life cycle, from development to post-market surveillance, and complements existing standards like IEC 82304-1 and IEC 62304. The article highlights the standards': ▶ Applicability: IEC 81001-5-1 is relevant to manufacturers of health software, encompassing both medical devices and other health-related software applications. It emphasizes the importance of collaboration between manufacturers and healthcare delivery organizations (HDOs) to ensure comprehensive cybersecurity measures. ▶ Requirements: The standard mandates the integration of cybersecurity processes within the quality management system, including: - Risk management for IT security. - Software development and maintenance processes. - Supplier evaluations to mitigate security risks. - Continuous improvement practices to address emerging cybersecurity challenges. ▶ Implementation Guidance: Annexes in the standard offer best practices on: - Secure coding techniques. - Threat analysis methodologies. - Development planning specific to health software requirements. ▶ Relation to Other Standards: IEC 81001-5-1 fills gaps in existing standards by providing detailed cybersecurity requirements specific to health software, thereby enhancing the overall security framework in the healthcare sector. https://lnkd.in/eJnxB7_G #Cybersecurity #HealthSoftware #IEC81001-5-1 #MedicalDevices #SoftwareDevelopment #RiskManagement #QualityManagement #HealthcareIT
IEC 81001-5-1: The standard for secure health software
https://blog.johner-institute.com
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🔐 Imagine this: A connected medical device is saving lives every day. But what if a hacker found a way to exploit a vulnerability in that device? The consequences could be catastrophic - not just for patient safety, but also for the manufacturer’s reputation. This is where Penetration Testing (Pentesting) comes into play. It's not just a technical exercise - it’s a comprehensive process that uncovers potential vulnerabilities and ensures a device is robust against cyber threats. What Does Pentesting for Medical Devices Involve? ▶ Test Planning: A tailored strategy to explore a device’s unique risk landscape. ▶ Protocols: Clear steps to simulate real-world cyberattacks. ▶ Test Execution: Simulating real-world cyberattacks on a system or device to identify vulnerabilities. ▶ Technical Test Report: Detailed documentation of vulnerabilities and potential impacts. ▶ Test Summary Report: Actionable insights to bolster cybersecurity. Why is Pentesting Crucial? ✅ Compliance: It addresses the FDA’s premarket cybersecurity requirements and other global standards. ✅ Proactive Defense: Identifies vulnerabilities before bad actors do. ✅ Patient Safety: Every uncovered vulnerability could prevent harm. At MedSecTesting, we’ve seen firsthand how pentesting transforms a device from vulnerable to virtually impenetrable. Our team dives deep to ensure that every connected device is prepared to face the evolving landscape of cyber threats. 💡 Remember: Cybersecurity is not a one-time effort - it’s a continuous process. If you’re developing or managing connected medical devices, let’s talk about how pentesting can make all the difference. #MedicalDeviceSecurity #Cybersecurity #PenetrationTesting #MedTech #PatientSafety #FDACompliance #CyberResilience #HealthTech #IoTSecurity #MedicalDeviceTesting #DeviceCybersecurity #ThreatManagement #CyberRisk #SBOM #SaMD
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𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐲𝐛𝐞𝐫𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐌𝐲𝐭𝐡𝐬 𝐁𝐮𝐬𝐭𝐞𝐝 🔍 Myth: Medical devices are too small or specialized to be hacked. ✅ Reality: Any connected device is a target. 🔍 Myth: Implementing cybersecurity will delay product launches. ✅ Reality: Proactive planning avoids delays and improves long-term efficiency. Let’s bust some more myths to build safer devices together. 💡 #CybersecurityMyths #MedDeviceSecurity #medicaldevice #cybersecurity
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MedSecTesting reposted this
Risk management in medical device software development is essential for ensuring patient safety, regulatory compliance, and product reliability. From identifying risks to post-market surveillance, a proactive and structured approach minimizes potential hazards. Early integration of risk management, thorough testing, and continuous monitoring are key to success. Remember, it's not just about compliance - it's about building trust and delivering safer healthcare solutions. #RiskManagement #MedicalDevices #SoftwareDevelopment #ISO14971 #IEC62304 #Cybersecurity #PatientSafety #RegulatoryCompliance #HealthcareInnovation
Risk Management in Software Development for Medical Devices
SDCentrum on LinkedIn
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MedSecTesting reposted this
Hi Brights, I’ll be speaking at the Engineering and Physical Sciences in Medicine Conference & Australian Biomedical Engineering Conference 2024. Let’s catch up if you’re planning to attend! #epsm #epsm2024 #conference #medicaldevice #cybersecurity
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The rise of AI-powered malware poses a significant threat to medical devices and patient data. This article outlines key strategies. By applying these strategies, device manufacturers will enhance the defence against advanced malware and ensure the safety and trustworthiness of their systems. #Cybersecurity #MedicalDevices #AI #MalwareProtection #PatientData #HealthcareSecurity #ThreatDetection #SBOM #RiskManagement
Protecting Medical Devices and Patient Data from Information-Stealing Malware
MedSecTesting on LinkedIn