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Provide trusted solutions that put patients first

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

Mdcrypt path to lead to success
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Actionable roadmaps

Medical device cybersecurity is a hard problem to solve. Our Services team provides actionable roadmaps to facilitate product development, quality, and security frameworks to meet your pre- and post-market needs. No matter where you are in your process, we enhance your processes and agile methodologies to get to market, while optimizing your resources.

Need cybersecurity strategy help

FDA cybersecurity readiness

Optimize your path to FDA cybersecurity readiness. We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you. Get your secure medical devices to market on or even ahead of schedule, with peace of mind.

FDA hold letter response

Get immediate guidance to navigate your response process effectively.

Threat modeling

Ensure your software ecosystem is protected and incorporate continuous security improvements into your design and engineering processes. We do a deep-dive investigation into your architecture, design, requirements, and implementation to create threat models that review current state, refine trust boundaries, identify requirements, and propose remediations, ensuring that your hardware, firmware, software, network communication, and data handling components to ensure you are protected now and in the future.

Cryptography design and review

We assess your PKI and certificate management practices, perform gap analysis with industry best practices and regulatory guidance, and develop realistic and actionable mitigation strategies for medical devices.

medcrypt logo

Actionable roadmaps

Medical device cybersecurity is a hard problem to solve. Our Services team provides actionable roadmaps to facilitate product development, quality, and security frameworks to meet your pre- and post-market needs. No matter where you are in your process, we enhance your processes and agile methodologies to get to market, while optimizing your resources.

Need cybersecurity strategy help

FDA cybersecurity readiness

Optimize your path to FDA cybersecurity readiness. We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you. Get your secure medical devices to market on or even ahead of schedule, with peace of mind.

FDA hold letter response

Get immediate guidance to navigate your response process effectively.

Threat modeling

Ensure your software ecosystem is protected and incorporate continuous security improvements into your design and engineering processes. We do a deep-dive investigation into your architecture, design, requirements, and implementation to create threat models that review current state, refine trust boundaries, identify requirements, and propose remediations, ensuring that your hardware, firmware, software, network communication, and data handling components to ensure you are protected now and in the future.

Cryptography design and review

We assess your PKI and certificate management practices, perform gap analysis with industry best practices and regulatory guidance, and develop realistic and actionable mitigation strategies for medical devices.

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Helping our customers succeed

All around the world, From startups to enterprise-level top device manufacturers are turning to Medcrypt we work with companies of all sizes to help secure their products.

Complexity with Third-Party Manufacturers? We've Got You Covered.
Many medical devices rely on third-party manufacturers for certain components or even the entire device, introducing significant complexity in maintaining consistent security standards. This fragmented supply chain can create vulnerabilities, especially when cybersecurity requirements are not uniformly applied.

Piccolo Medical
Piccolo Medical

“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

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

Ayan Desai
Ayan Desai
Staff Quality Engineer,
Iota Biosciences

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.

Merlin Nunez
Merlin Nunez
Platform Engineer,
Ypsomed

Helping our customers succeed

All around the world, From startups to enterprise-level top device manufacturers are turning to Medcrypt we work with companies of all sizes to help secure their products.

Complexity with Third-Party Manufacturers? We've Got You Covered.
Many medical devices rely on third-party manufacturers for certain components or even the entire device, introducing significant complexity in maintaining consistent security standards. This fragmented supply chain can create vulnerabilities, especially when cybersecurity requirements are not uniformly applied.

Piccolo Medical
Piccolo Medical
,

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.

Merlin Nunez
Merlin Nunez
Platform Engineer,
,
Ypsomed
Ypsomed

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

Ayan Desai
Ayan Desai
Staff Quality Engineer,
,
Iota Biosciences
Iota Biosciences

"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
,

"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
,

"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
,

“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
FIRE1 Foundry

"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
 Qlife

“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
Tenac.io
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Our FDA experts by your side

We are FDA and medical device experts helping healthcare technology companies build products that are secure by design.

Naomi Schwartz

Naomi Schwartz

VP of Services
Seth Carmody

Seth Carmody

VP of Regulatory Strategy
Clayton McNeil

Clayton McNeil

VP of Engineering
AJ Reiter

AJ Reiter

Director, Strategy and Organizational Transformation
ON-DEMAND WEBINAR

FDA ‘Cybersecurity Refuse to Accept Policy’ (RTA)

Medcrypt’s own FDA expert, Naomi Schwartz, discusses what the new policy means for MDMs.

Watch video
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Are you FDA-ready?

Get your secure medical devices to market on or even
ahead of schedule, with peace of mind.