The futureof medical devices is secure by design

Rapidly move through FDA compliance to secure device management with our expert services and time-saving solutions.

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Who is Medcrypt and what do we do?

We believe connected health technology has the power to drastically improve quality of life, reduce costs, and solve unmet medical needs.

More about Medcrypt

Backed by

Johmsons and johnsons
Intuitive ventures
dexcom ventures
Y combinator
Section 32
Eniac ventures
Anzu Partners
Dolby Family Ventures

Meet FDA cybersecurity requirements

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.

FDA Security

Simple, yet powerful cybersecurity

We help safe and effective technologies get to patients quickly:

SBOM & vulnerability management

Helm provides full visibility across all your medical devices’ software supply chain to detect, prioritize, and remediate cybersecurity risk.

Secure existing & new devices

Our Guardian platform enables you to build devices that are secure by design. Automate device provisioning and certificate/key management.

Monitor devices in the field

Canary captures medical device behavior data, giving you visibility into potential security related incidents even for devices with limited connectivity.

SBOM & vulnerability management
Guardian
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Where in the FDA requirement lifecycle is your business?

I’m ready to file & need a cybersecurity check

I received an FDA refusal

I need FDA hold letter guidance

Deliver care safely to patients

Our products and services are optimized for medical device manufacturers to build secure, innovative medical devices faster while meeting FDA cybersecurity requirements.

I have an SBOM, now what?
I have too many vulnerabilities! Where do I start?
I need my device to communicate securely
I need to secure code signing
I need to monitor my devices
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Helping our customers succeed

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!”

Mathias Ottitsch

Mathias Ottitsch

CTO
,
Tenac.io

"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."

Michael Agerkvist Petersen

Michael Agerkvist Petersen

Product Owner
,
Qlife

“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.”

Michael Kelly

Michael Kelly

Software Engineering Manager
,
FIRE1 Foundry

FDA readiness

Prepare for FDA cybersecurity readiness via regulatory strategy, penetration testing, threat modeling, process optimization, and more.

Take the survey
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Recent articles from Medcrypt

Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment
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Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment

Thought leadership
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Vulnerability management
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Axel Wirth
Axel Wirth

March 1, 2024

HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)
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HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)

Regulatory
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Thought leadership
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Vulnerability management
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Tools & processes
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Axel Wirth
Axel Wirth

February 26, 2024

Meet the Experts: Naomi Schwartz
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Meet the Experts: Naomi Schwartz

Company
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January 29, 2024

Progress through new FDA regulations with experts at your side

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