Introducing Helm, the improved SBOM and vulnerability management tool

Secure your market edge with a comprehensive cybersecurity solution tailored for FDA compliance.
Explore our pricing

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.

Introducing Helm, the improved SBOM and vulnerability management tool

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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

Ensure your devices are secure by design with a comprehensive cybersecurity solution that meets FDA requirements and guidelines

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
helm dashboard

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

"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"

Medical Device Manufacturer

Medical Device Manufacturer

,

"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

"Medcrypt's structured approach to document review was very helpful. We liked their guidance and enjoyed working with the Medcrypt team."

Presidio Medical

Presidio Medical

,

"We were thinking it was going to take a month to get an SBOM and Medcrypt provided it in 3 days"

Top Medical Device Manufacturer

Top Medical Device Manufacturer

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FDA readiness

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

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Recent articles from Medcrypt

FAQ on Operating Systems (OS) for Medical Devices
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FAQ on Operating Systems (OS) for Medical Devices

Vulnerability management
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Thought leadership
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Tools & processes
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July 12, 2024

Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices
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Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices

Thought leadership
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Company
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Mike Kijewski
Mike Kijewski

July 3, 2024

The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?
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The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?

Thought leadership
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Regulatory
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Sara Farnsworth
Sara Farnsworth

July 3, 2024

Progress through new FDA regulations with experts at your side

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