If your company manufactures medical devices, cybersecurity needs to be an ongoing priority. However, it is particularly important in the pre-market phases as you will not secure FDA (or equivalent global regulatory body) approvals.
Frankly, preparing your MedTech for FDA submissions requires the help of a dedicated cybersecurity team that specializes in the industry. Otherwise, inadequacies will cost you approvals or, worse still, compromise patient safety if you somehow pass.
Several experts in this arena are available, but you only need one. We’ve shortlisted the best to help you select one you can rely on for all of your future medical device cybersecurity needs.
1 Blue Goat Cyber
Blue Goat Cyber is a leading specialist in this sector of cybersecurity that is committed to “ensuring the security and trustworthiness of medical devices in an ever-evolving digital landscape”, working with startups and large manufacturers of medical devices alike.
The company’s founder, Christian Espinosa, is passionate about the industry having benefited from life-saving medical devices himself. His desire to support manufacturers throughout the FDA and regulatory approval process with full-service medical device cybersecurity has accelerated hundreds of applications, ultimately resulting in products coming to market sooner to change lives while simultaneously removing online vulnerabilities.
Blue Goat Cyber provides an extensive range of services across the pre-market FDA-approval journey, which can be used individually or combined in a package. They include;
- Secure MedTech Product Design Consulting
- Medical Device Penetration Testing Services
- Software Bill of Materials (SBOM)
- Static Application Security Testing (SAST)
- Threat Modeling
- FDA Medical Device Cybersecurity Deficiency Response
Blue Goat Cyber additionally offers dedicated Medical Devices Postmarket
Cybersecurity Solutions, as well as a range of Penetration Testing services (FDA-Compliant Vulnerability & Penetration Testing, SOC 2 Penetration Testing, Web Application Penetration Testing, White Box Penetration Testing, Gray Box Penetration Testing, Black Box Penetration Testing, API Penetration Testing, Application Penetration Testing, Internal Penetration Testing, Mobile Application Penetration Testing.
This means that the robust cybersecurity solutions aimed at both regulatory compliance and patient safety can be used throughout the lifecycle of a medical device.
Velentium Medical, previously known as just Velentium until earlier in 2025, doesn’t only specialize in cybersecurity for MedTech. It is a company with a rich history in the design, development, and engineering of medical devices. This gives the company’s experts a clear understanding of the thought processes innovators have, as well as the FDA approval challenges that they may face. This connection is celebrated by close working partnerships.
The company offers tailored services that can support startups and global organizations alike. Preparing to satisfy FDA cybersecurity expectations, IEC 62304, and other regulatory frameworks becomes far easier with their help. Theory solutions are also fully scalable while also providing device-specific strategies that can be embedded from concept to completion.
3I Nova Leah
Nova Leah is a “world leader in the provision of cybersecurity risk management solutions for connected device manufacturers and system integrators”. It is best known for its automated SelectEvidence platform, which guides manufacturers of medical devices through the pre-market process. As well as FDA approvals, its impact can be extended to EU, MDR, and other regulatory compliance rules. This makes it suitable when reaching new territories.
The automated risk management process can be used to manage SBOMs, mitigate threats, meet new FDA requirements, and enhance entire risk management processes. Threat modeling, risk scoring, and mitigation recommendations are tailored with MedTech devices in mind. Cybersecurity documentation will also be prepared for FDA submission.
4I Cybellum
Cybellum doesn’t only provide cybersecurity solutions for medical device manufacturers in the pre-market phases. The company also serves clients in the industrial and automotive sectors. Still, its product security platform is ideal for regulated industries like MedTech. Its pre-market cybersecurity features deliver automated SBOM generation, vulnerability discovery, and attack surface mapping with a focus on FDA, IEC 62443 and other compliance
By bringing cybersecurity to the development process, last-minute changes ahead of submissions can be avoided. This allows the pre-market phase to progress smoothly without delays, creating cyber-secure devices that can be released to market far sooner. Similarly, it mitigates the risks of product recalls. The platform itself keeps all matters in one dashboard too.
5I MedSec
Founded in Florida, MedSec is one of the longest-standing medical device security firms on the planet. It has helped prepare thousands of devices for FDA approvals by promoting compliance and patient safety. Its comprehensive pre-market services cover technical penetration testing, threat modeling, and secure design. The company has also been a leading voice in inspiring change in global healthcare security standards and regulatory practices.
MedSec is a firm focused on identifying and mitigating issues before submission rather than facing lengthy rectification processes after a rejection. Manufacturers of medical devices may use the services for FDA, EU MDR/IVDR and other regulatory bodies. Its aim is to “develop innovative, cost-effective security solutions” that are the catalyst for quick paths to market.
6I Asimily
Asimily is an IT, IoT, OT and IoMT cybersecurity and risk mitigation specialist that manages potential exposures with a next-generation that provides protection across the entire cyber asset attack surface. While it serves companies in many industries, its sector-specific practices for MedTech certainly stand out. Comprehensive vulnerability management includes detailed looks into potential device weakness, and what they can mean for FDA approvals or patient safety.
Deep insights into behaviors, configurations, and software components guide companies to the correct responses. In turn, it is possible to build more robust systems that satisfy the demands of all pre-market submissions. This can prevent the risk of rejections, which then cause delays or redesigns, as well as a loss of momentum. Data-driven approaches yield great results.
The Final Word
When preparing medical devices for market, cybersecurity is an essential feature for gaining compliance and providing a safer product for patients. However, in an ever-evolving landscape of new threats, it’s imperative that you partner with a specialist that helps you retain control while also aligning with your needs and budgets.
All of the six above can do this with quick FDA approvals in mind. The road to market starts now.
Editor-in-Chief | Seat42F, a leading source of entertainment news, information, television and movie resources.
