We believe connected health technology has the power to drastically improve quality of life, reduce costs, and solve unmet medical needs.More about Medcrypt
We know that each day of delay to market, or lost data causes risk to the business. Medcrypt is here to help you quickly meet the regulatory and compliance requirements as set by the FDA, maintain cybersecurity posture over a device's lifetime, and support ongoing clinical care delivery.
We help safe and effective technologies get to patients quickly:
Our products and services are optimized for medical device manufacturers to build secure, innovative medical devices faster while meeting FDA cybersecurity requirements.
By having an SBOM that represents the current state of your product, you can create a catalog of all of your “ingredient lists” to create visibility and transparency across your software security supply chain, as well as identifying any potential exploitable vulnerabilities you need to assess and mitigate.
Our continuous Software Bill of Materials (SBOM) and vulnerability tool is built specifically for medical device manufacturers (MDMs), providing full visibility across your entire medical devices’ software supply chain to detect, prioritize, and remediate cybersecurity risk.
Guardian provides flexible options to meet your security requirements. You can embed source code into your device or install an agent on your device, with minimal impact to your R&D process.
Guardian can be used to sign firmware and software, which can be verified on the device before a firmware update, or as an application or configuration is loaded.
From startups to enterprise-level, top device manufacturers are turning to Medcrypt. We work with companies of all sizes to help secure their products.
“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!”
"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.”
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March 1, 2024
February 26, 2024