Compliance Focus
ACHIEVING EU MDR, HIPAA AND FDA COMPLIANCE
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, HIPAA and FDA standards and regulations. They will work closely with you, ensuring you understand the processes and how cybersecurity 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.
MEDICAL DEVICE STARTUPS, SCALE-UPS, AND ENTERPRISES LOOKING TO ENTER THE SPACE.
Why Penetration Testing Matters
For Medical Devices
As connectivity within the healthcare ecosystem increases, medical devices are now prime targets for cyberattacks. A single vulnerability could allow unauthorised access, alter device function, or expose sensitive patient data.
Services
WE HAVE A VARIETY OF SERVICES SPECIFIC TO ENSURING THE SECURITY OF YOUR MEDICAL DEVICES.
Conducting a thorough hazard analysis is crucial for ensuring the safety and compliance of medical devices. Hazard analysis identifies potential risks and evaluates their impact on patient safety and device performance. At Periculo, we offer expert hazard analysis services to help you systematically identify, assess, and mitigate risks throughout the product lifecycle. Our approach includes detailed risk assessments, failure mode and effects analysis (FMEA), and the development of robust mitigation strategies. With Periculo’s support, you can ensure that your medical devices meet regulatory standards, enhance patient safety, and maintain high levels of performance and reliability.
Frequently Asked Questions
FIND OUT MORE ABOUT WHAT WE DO
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.