Building a Secure Device for Healthier Lives

Is your medical device compliant with the recently ratified FDA cybersecurity guidance from September 2023? While your device might be secure, navigating the documentation requirements can be daunting. With over 30 years of experience in software, we understand the intricacies of the cybersecurity landscape. Let our experts help you ensure your submission doesn’t hit a roadblock.

Featured Design & Development Services

Enhanced Security Assurance

Combat rising cybersecurity threats with our proactive measures, ensuring the safety of your medical devices in an increasingly connected world.

Tailored Risk Management

Benefit from customized cybersecurity strategies tailored to your device's unique vulnerabilities, meeting standard FDA guidelines for heightened protection. We will help your device meet security industry standards.

Regulatory Excellence

Leverage our expertise in FDA and EU regulations to design and deliver compliant medical devices, prioritizing patient safety without compromising innovation.


Hear From Our Happy Clients

Our clients’ experiences speak volumes about our commitment to innovation and quality. Here, you can read firsthand accounts of how Vantage MedTech has positively impacted various medical technology projects.
My relationship with Vantage MedTech spans three different companies and 15 years. I return to the Vantage MedTech team because they consistently deliver innovative solutions in a timely and cost-effective manner. I plan to continue this relationship for many years to come!
Vantage MedTech has provided us with a broad range of expertise, from electrical and software design to quality assurance and regulatory affairs. It would have been unlikely we could have hit our scheduled milestones without their help.
We were a young start up with a great technology, but were running into issues that our manufacturing partner could not explain. Over a year later and still no clear solution, I engaged Vantage MedTech to perform an independent analysis. Within 24 hours, they not only identified the issue, but also presented solutions to correct it. Vantage MedTech came forward with the level of expertise that was necessary to help turn around the situation, allowing REACT to bring our advanced neuromuscular therapy to patients who need it.
I have had the pleasure of working with Vantage MedTech team for the past seven years. The Vantage team is extremely professional, responsive, and collaborative. I know that I can always count on the Vantage MedTech Team to provide a quality product that will meet the product requirements.

Director of R&D

Several Medical Device & Life Sciences Firms


Katalyst Surgical

Kenneth C. Paulus

Founder & CEO, REACT Holdings & Pelvic Wave

Peter J. Oehlberg

Director, Technical Operations Bracco Diagnostics Inc

Your innovations are invaluable. Shield them from cyber threats today.

Safeguard medical innovations with our tailored medical device security solutions and developing the correct cybersecurity risk documentation the first time. Stay compliant and secure in today’s healthcare environment.

Rely on partners who can adapt to your needs, wherever you are in your journey

Our depth of expertise in specific clinical segments is strengthened by our dedicated team, refined processes, and specialized portfolio and proprietary platforms.

Years of experience
Specialized medical device engineers
On time delivery
Medical devices successfully developed
Experienced Partner

Reduce execution risk by working with a medical device software company known for over 1,600 medical devices successfully delivered.

Advantage Platforms®

Leverage our proprietary platform architecture and reduce development timelines by up to 60%.

Expert Team Collaboration

Our in-house team of specialized engineers will bring your medical device from concept to reality with precision and care.


Frequently Asked Questions

When is medical device cybersecurity?

Medical device cybersecurity involves protecting medical devices and their associated systems from potential cyber threats, such as unauthorized access, data breaches, and malware attacks.

Why is medical device cybersecurity important?

Ensuring cybersecurity for medical devices is crucial for safeguarding patient safety, maintaining data integrity, and complying with regulatory requirements. Cybersecurity breaches can compromise the functionality of medical devices, pose significant risks to patient health, and carry the possibility of reputational or financial harm to the owner/manufacturer of a medical device.

What types of cyber threats do medical devices face?

Medical devices face various cyber threats, including malware attacks, data breaches, ransomware, and unauthorized access. These threats can lead to device malfunction, data loss, and potential harm to patients.

How does Vantage MedTech address medical device cybersecurity?

Vantage MedTech employs proactive cybersecurity measures, including threat modeling and risk analysis, vulnerability testing, all in compliance with FDA and EU regulations. We tailor our solutions to each device's unique vulnerabilities, ensuring robust protection against cyber threats.

What steps can I take to enhance medical device cybersecurity?

To enhance medical device cybersecurity, it's essential to conduct regular risk assessments and proactive vulnerability monitoring, implement secure authentication mechanisms, keep devices updated with the latest security patches, and educate users about cybersecurity best practices.

What regulatory standards govern medical device cybersecurity?

Regulatory standards for medical device cybersecurity include guidelines from the FDA, such as the Pre-Market Cybersecurity Guidance and the Post-Market Management of Cybersecurity in Medical Devices. Additionally, the EU's Medical Device Regulation (MDR) mandates cybersecurity requirements for medical devices sold in Europe, while compliance with the EU General Data Protection Regulation (GDPR) is also essential for safeguarding patient data and privacy.

How can I ensure compliance with medical device cybersecurity regulations?

Ensuring compliance with medical device cybersecurity regulations involves conducting thorough risk assessments, implementing appropriate security controls, documenting cybersecurity measures, and staying informed about regulatory updates and guidelines. This also requires a comprehensive plan to continuously monitor devices for cybersecurity incidents or emergence of new vulnerabilities, along with strategies to detect, respond, and recover in the event of a cybersecurity incident.