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Ensuring Compliance in Medical Device Cyber Security
Medical Device Security
Compliance is a critical aspect of medical device security, we understand that regulatory standards are stringent and the importance of adhering to regulations like HIPAA and FDA guidelines. We have simplified solutions to allow you to start, grow and scale. Let us remove the headache of security compliance.
Cybersecurity for Medical Devices
Overview
We're here to support you with your medical device security journey through the complexities of compliance with standards like the EU MDR and FDA.
An assigned expert will help you navigate and understand the EU MDR, HIPPA and FDA standards and regulations. They will work closely with you, ensuring you understand the processes and how cyber security is embedded within them.
Not only do we advise and support, we can manage the processes for you with our qualified team, saving you time and effort.
Our Medical device security experts have put together a series of guides and support documents to help with achieving EU MDR and FDA compliance - you can check out our blog posts for support.
Who is this for?
Medical device startups, scaleups and enterprises looking to enter the space
What does it cost?
Dependant on the level of support you need, we can tailor a service to you.
Achieving EU MDR, HIPAA and FDA Compliance
How it works
Book a call
Everyone is different and medical devices aren't the same. It's important that we have some time to understand exactly what you need to be able to advise accordingly.
Select your services
We offer adhoc services for business that need a one off engagement, for example penetration testing. Or a managed service for any processes that you would like to have improved whilst saving you time to grow your business.
Grow your business
We have used security as a selling point for many medical device companies. Impress new customers when submitting RFPs, reduce your overheads and more forward with clarity.
Partnership
Our business model is to grow with our customers, this means we focus on building a partnership based on trust. It is in our best interest to provide you with the best possible service at the best level of quality.
Services
We have a variety of services specific to ensuring the security of your medical device
Enhance patient safety and achieve regulatory compliance with our expert hazard analysis services. We meticulously identify and assess potential risks in your medical devices, ensuring you can mitigate hazards effectively. Optimise your device safety and meet industry standards with our comprehensive approach.
Protect your medical devices from cyber threats with our specialised penetration testing services. We simulate real-world cyber-attacks to uncover vulnerabilities, providing you with detailed assessments and actionable insights. Strengthen your device security and safeguard patient data with our expert penetration testing.
Maintain precise control over your Software Bill of Materials (SBOM) with our professional SBOM management services. We offer tools and expertise to keep accurate records of software components, ensuring regulatory compliance and enhancing supply chain transparency. Streamline your SBOM management with our solutions.
Navigate FDA regulations effortlessly with our comprehensive FDA compliance services. We guide you through the complexities of regulatory requirements for medical devices, ensuring a smooth approval process. Achieve and maintain high standards of safety and efficacy with our FDA compliance expertise.
Achieve ISO13485 certification seamlessly with our expert guidance. Our ISO13485 compliance services help you align your quality management system with international standards, ensuring consistent quality and regulatory compliance for your medical devices. Simplify your certification process with our support.
Secure your medical devices from the ground up with our Secure Development Lifecycle (SDL) services. We integrate robust security measures at every development phase, protecting your products from vulnerabilities and ensuring compliance with industry regulations. Build secure, reliable medical devices with our SDL expertise.
we specialise in helping healthcare providers and medical device manufacturers implement the NIST Cybersecurity Framework to safeguard against cyber threats. Our services include comprehensive risk assessments, vulnerability testing by CREST-certified penetration testers, and tailored framework alignment. We also provide compliance support, incident response planning, and continuous monitoring to ensure your medical devices remain secure and compliant with regulations like HIPAA and FDA guidelines.
Increase your contract success rate with our professional RFP support services. We assist in crafting compelling and compliant proposals that highlight your strengths and meet client requirements. Enhance your proposals and secure more contracts with our expert RFP support.
Ensure your medical devices comply with the European Union Medical Device Regulation (EUMDR) with our comprehensive services. We provide detailed guidance on meeting regulatory requirements, ensuring your products are safe, effective, and market-ready. Stay compliant and competitive with our EUMDR expertise.
Meet international standards for medical device software with our IEC62304 compliance services. We assist you in implementing and maintaining a compliant software development lifecycle, enhancing the safety and reliability of your products. Ensure your software meets regulatory requirements with our IEC62304 expertise.
Still have questions?
Have a call with our founder or one of our experts to put together a free action plan.
FAQs
Find answers to commonly asked questions about medical device cyber security.
Medical device cyber security refers to the protection of medical devices from unauthorised access, use, disclosure, disruption, modification, or destruction.
Cyber security for medical devices involves protecting these devices from cyber threats like hacking, malware, and unauthorised access. As medical devices become more connected, they face risks similar to traditional IT systems. Ensuring cybersecurity means safeguarding both the functionality of the devices and the sensitive patient data they handle. This includes implementing encryption, adhering to regulations like HIPAA and FDA guidelines, and continuously monitoring for threats. The goal is to ensure these devices remain secure, reliable, and safe for patient care.
Several regulations apply to the security of connected medical devices, including:
HIPAA (Health Insurance Portability and Accountability Act): This ensures the protection of patient data, which is often managed by connected medical devices.
FDA (Food and Drug Administration) Guidelines: Provide specific recommendations for the cybersecurity of medical devices throughout their lifecycle.
GDPR (General Data Protection Regulation): Applicable in the EU, it mandates the protection of personal data, including that handled by connected medical devices.
To ensure the security of medical devices, keep software updated, implement strong access controls, use secure networks, perform regular vulnerability assessments, and train staff on cybersecurity best practices. Be aware of threats like malware, unauthorised access, data breaches, and device tampering. Adhere to regulations such as FDA guidance, HIPAA, EU MDR, and the NIST Cybersecurity Framework. Detect and respond to incidents with continuous monitoring, automated alerts, a dedicated response team, forensic analysis, and recovery plans. At Periculo, we specialise in helping organisations maintain medical device security, ensuring patient safety, data protection, and regulatory compliance.
The security of connected medical devices is crucial because these devices handle sensitive patient data and often play a direct role in patient care. A cyber attack on a connected medical device can lead to device malfunction, unauthorised access to patient information, or even direct harm to patients. Ensuring these devices are secure helps protect patient safety, privacy, and the overall integrity of healthcare systems.
While these regulations have similar goals, they may have slightly different requirements and focus on different aspects of device security. For example, the EU MDR places a stronger emphasis on post-market surveillance, while the FDA's regulations focus more on pre-market clearance or approval.
Drop your email and we will organise a call
Free strategy session to help you improve your device and a free vulnerability scan to use when you like.
Patrick Harding
CEO, Joy
