Our products and services are optimized for medical device manufacturers to build secure, innovative medical devices faster while meeting FDA cybersecurity requirements.
The manual checklist approach is no longer effective, as regulatory complexity rises with Section 524B and Al devices. Continuous, integrated, data-driven security processes are essential for compliance in the evolving landscape.
19 successful clearances in the “New Era” of tight regulation (including 7 in 2024 and 6 projected for 2025)
Our automated approach is the gold standard for the “High Bar” submissions
Proven success in De Novo and PMA submissions for life-sustaining devices where manual methods fail
Our team helped write the JSP and FDA guidance, then supported hundreds of real-world submissions.
The Launchpad
Designed for Startups, Single-Product Teams facing an immediate regulatory deadline, and Legacy Devices needing a regulatory check-up
Access to proven templates built from hundreds of FDA interactions
Expert led sessions to work through up to two areas of concern
Automated gap analysis that mimics an FDA reviewer’s deep dive
One license to establish a machine-readable SBOM and basic CVE tracking
Transforms your team from “box-checkers” to “launch-ready” by automating the 2010-era manual paperwork that usually causes RTAs.
The Product Security - Force Multiplier
Created for MDMs needing to solve the “Mountain of Data” and maintain market access. Ideal for standard 510(k) submissions and IoT devices
Threat modeling, penetration testing, and automated document development & maintenance that stays in sync with software sprints
Maintain continuous compliance with real-time monitoring across all devices, ensuring immediate visibility and automated escalation whenever security deviations occur or are proposed
Beyond just listing CVEs, MSI provides a prioritized remediation list (turning 1,000+ noisy hits into the 5–10 items that actually impact patient safety)
Ongoing access to MedCrypt’s aggregate experience — allowing you to answer “Can we submit with an end-of-life OS?” with data, not guesses
Includes MedISAO and a “Security Fact Sheet” builder to help you clear customer security questionnaires (avoiding the $100k-per-day procurement stall)
The Strategic Intelligence Hub
Engineered Large-scale MDMs managing enterprise-wide risk and security debt. Tailored navigate complex regulatory challenges & Cloud and AI ecosystems
Provides visibility across a large product portfolio to see which teams are lagging and which are leading
Data-driven metrics on how your security posture, and FDA feedback trends, compares to peers
Specialized strategies for “de-risking” legacy devices (Windows 7/Android 7) without requiring a total redesign
Translates technical gaps into Dollar-based Risk Models (Annual Loss Exposure) to justify budget to the Board and C-Suite
Specific access for “Hair-on-Fire” FDA Hold letters
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“In the course of filing for a 510(k) clearance we needed to establish a threat model that meets regulators' expectations. Medcrypt not only helped us with their deep expertise but even more with the excellent understanding of our company specific needs. If you are looking for tailor-made solutions, provided by people who really care, Medcrypt are the folks to turn to!”
"After talking to Medcrypt about our FDA submission and the proposed changes to the FDA's guidance we realized this was the perfect time for this engagement. There was added value at all levels and we got the best value out of it. We have tangible steps on how to evolve and we are now set up to deal with the FDA in the future. Medcrypt described all of our submission deficiencies beautifully and we were able to understand what needed to be done based on your explanations. Medcrypt paid attention to us and it was clear they wanted us to succeed"
We appreciate all the help from the Medcrypt team and the clearance would not have been possible without your contributions.
"As a startup medical device company with a new product under development, including a cloud-based component, we needed to improve cybersecurity in order to protect our business and get IVDR CE-mark and FDA 510(k) clearance. MedCrypt helped us develop our threat model, which guided us to a more secure design and improvements to our solution architecture. MedCrypt has also been deeply involved in creating our cybersecurity risks and meet future regulatory expectations. We are extremely satisfied with the support we received from MedCrypt and recommend MedCrypt if you are looking for a partner to help with your medical device cybersecurity program and design."
“Medcrypt’s support increased our confidence in our cryptography architecture, helped us better document its strengths, and provided feedback on gaps in other areas. From our work with Medcrypt, we expect a faster and smoother regulatory review, as well as faster development of our roadmap.”
"Medcrypt's structured approach to document review was very helpful. We liked their guidance and enjoyed working with the Medcrypt team."
"We were thinking it was going to take a month to get an SBOM and Medcrypt provided it in 3 days"
The diversity of experience within the Medcrypt team was really beneficial to us. We talked about everything from cybersecurity to basic software design principles and even unrelated physical phenomena, such as EMI and were able to get fast answers to our questions. We were impressed with the level of bespoke support we received. We liked that we could reach out to the reviewers at Medcrypt with ad hoc questions whenever they came up.
With respect to our submission, the FDA didn't have questions related to cybersecurity or software following our engagement with Medcrypt. Additionally, we recently had an internal audit and the auditors were very happy with the quality of the documentation that we had for both cybersecurity and software development.I would rate Medcrypt's services as exceptional quality
Helm is better organized and the reports it produces are friendlier to humans than Dependency Track. Also, the Alias feature in Helm is not present in Dependency Track which is a big point for us. Dependency Track seems to be quite a bit more prone to false positives than Helm.
