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The only medical device cybersecurity team with 100% FDA approval

The Medcrypt difference: 

  • Led by former FDA policy reviewers who know exactly what regulators want to see
  • 100% FDA approval rate since 2023
  • AINN response time reduced from 180 to 45-60 days
  • 200+ successful projects across 60+ clients
  • 100% guarantee for new customers: If you follow our guidance and your product meets cybersecurity expectations, we’ll support you through all FDA feedback — until your cybersecurity documentation is accepted.
  • No hidden fees. No handoffs. Just expert support.

Each of our customers who needed help navigating cybersecurity documentation requirements for FDA submissions has had a 100% success rate. 

Now, we’re offering a 100% guarantee for new customers: If you follow our guidance and your product meets cybersecurity expectations, we’ll support you through all FDA feedback — until your cybersecurity documentation is accepted.

No hidden fees. No handoffs. Just expert support.

Expert cybersecurity regulatory compliance for medical devices throughout your device lifecycle

Medical device cybersecurity is a hard problem to solve

Medcrypt's cybersecurity services - led by ex-FDA reviewers and policy experts - streamline compliance, enhance security, and protect your devices from development to post-market.

Pre-market services

Ensure regulatory readiness

Getting your medical device through FDA approval requires more than just great technology — it demands cybersecurity expertise that regulators trust. Our pre-market services, led by former FDA policy experts, ensure your device is secure by design and submission-ready from day one.

What pre-market cybersecurity means:

Pre-market cybersecurity focuses on building security into your device before FDA submission. This includes establishing your cybersecurity framework, conducting comprehensive risk assessments, implementing proper cryptographic foundations, and creating the documentation FDA expects to see.

Why it matters:

  • Faster approvals: Our clients reduce AINN response time from 180 days to just 45-60 days
  • 100% success rate: Since 2023, 100% of customers using Medcrypt services have successfully achieved FDA approval
  • Avoid costly delays: Proper pre-market planning prevents expensive redesigns and regulatory setbacks
  • Future-proof foundation: Build security architecture that supports both compliance and post-market updates
  • Global market access requiring diverse regulatory compliance capabilities

Our proven approach

We integrate cybersecurity into your quality management system using FDA-recognized frameworks like TIR-57/SW96. Our former FDA reviewers know exactly what regulators look for, helping you build documentation and security controls that meet or exceed expectations.

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Regulatory cybersecurity readiness

Navigate regulatory complexities with ease. Whether preparing a submission or addressing FDA requests for additional information, our experts work with you to achieve FDA clearance or approval efficiently.

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Threat modeling & risk mitigation

In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the responseprocess effectively.

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Cybersecurity maturity assessments

Comprehensive security benchmarking

Advance your security posture with detailed assessments that benchmark your current cybersecurity capabilities against FDA expectations and industry best practices.

Expert FDA review process

Our former FDA reviewers conduct deep-dive evaluations of your security architecture, processes, and documentation, identifying specific gaps that could delay regulatory approval.

Actionable improvement roadmap

Get a detailed improvement roadmap with prioritized recommendations, timeline estimates, and resource requirements to achieve FDA-ready security maturity before submission.

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PKI & cryptography analysis

Ensure a secure foundation with expert analysis of and improvement for your cryptographic design, including assessments that any PKI employed follows best practices and aligns with regulatory expectations to strengthen device security at scale

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FDA hold letter response

In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the responseprocess effectively.

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SDLC integration

Development process integration

Our experts help you integrate SBOM generation, vulnerability scanning, and security testing considerations into your development lifecycle, ensuring continuous security validation throughout development.

Scalable compliance tracking

We help you establish workflows that integrate threat detection, security documentation, and compliance tracking into your development process, ensuring they scale with your team and meet FDA's software lifecycle requirements.

Post-market services

Device lifecycle management

Medical device cybersecurity doesn't stop at FDA approval. Post-market compliance ensures ongoing patient safety, regulatory adherence, and device integrity in an evolving threat landscape. Our post-market services help manufacturers maintain regulatory cybersecurity compliance and safeguard device integrity against emerging threats after FDA approval.

What post-market cybersecurity means:

Post-market cybersecurity involves continuous monitoring, vulnerability management, incident response, and regulatory compliance maintenance throughout your device's long lifecycle. As new threats emerge and regulations evolve, your security posture must adapt while maintaining patient safety and regulatory compliance.

Why it's critical:

  • Patient safety: Proactive threat monitoring protects patients from emerging cybersecurity risks
  • Regulatory compliance: Meet ongoing FDA requirements for post-market cybersecurity management
  • Business continuity: Rapid incident response minimizes device downtime and reputational damage
  • Cost management: Structured vulnerability management reduces emergency response costs
  • Global market access requiring diverse regulatory compliance capabilities

Trust our experts

Medcrypt boasts the only Services team with former FDA reviewers who will ensure your success — 100% guaranteed.

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Cybersecurity risk management

Expert-driven risk prioritization

We help you identify which cybersecurity risks actually threaten patient safety versus those that can be deprioritized, ensuring your limited security resources focus on the vulnerabilities that matter most to regulators and patients.

Patient-focused threat assessment

We help you prioritize threats based on patient safety impact, exploitability, and regulatory requirements using proven methodologies.

Strategic risk roadmap

We assess your security posture, help you prioritize risks, and develop a strategic roadmap that aligns security investments with industry standards and regulatory requirements.

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SBOM validation & monitoring

Automated SBOM validation and continuous monitoring to track and mitigate emerging vulnerabilities in third-party components, helping ensure compliance with regulatory requirements.

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Regulatory change management & compliance updates

Proactive regulatory monitoring

Stay ahead of rapidly evolving cybersecurity regulations with our comprehensive change management services that translate new requirements into actionable steps.

Expert guidance translation

Our regulatory experts continuously monitor FDA, CISA and other regulatory requirements, translating new guidance into specific into actionable steps for your devices and keep your device security and documentation aligned with the latest compliance expectations.

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Cybersecurity incident response

Prepare for real-world threats with our Incident Response Tabletop Exercise. We simulate attacks to test, refine, and validate your response plans - ensuring proper preparation,  rapid detection, effective containment, and appropriate follow-up — reducing impact and protecting your company’s reputation.

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Vulnerability management & patch strategy development

We'll work with you to establish robust processes for continuous monitoring of vulnerabilities and threats. This includes developing regulatory-compliant patching and update strategies to ensure the ongoing integrity of your medical devices and generate metrics to track your successes.

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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.

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Pre-market services

Accelerate FDA approval with expert guidance from those who know the process inside and out.

Get pre-market help now!

Regulatory cybersecurity readiness

Navigate regulatory complexities with ease. Whether preparing a submission or addressing FDA requests for additional information, our experts work with you to achieve FDA clearance or approval efficiently.

FDA hold letter response

In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the response process effectively.

Threat modeling & risk mitigation

Navigating FDA cybersecurity requirements is complex. Our experts simplify the process using the AAMI TIR- 57/SW96 framework, helping you develop or refine your Threat Model and Cybersecurity Risk Assessment to align with your device’s Risk Management Process from analysis to review.

PKI & cryptography analysis

Ensure a secure foundation with expert analysis of and improvement for your cryptographic design, including assessments that any PKI employed follows best practices and aligns with regulatory expectations to strengthen device security at scale

Cybersecurity maturity assessment

Advance your security posture with a tailored assessment that benchmarks your security capabilities, identifies gaps, and provides a roadmap for improvement.

Secure development lifecycle (SDLC) integration

Our tailored cybersecurity trainings incorporating industry-leading best practices citing global regulatory guidances and standards. Medcrypt will educate your team in the critical cybersecurity elements to incorporate into your device lifecycle.

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Post-market services

Medical device cybersecurity doesn’t stop at FDA approval

Postmarket compliance ensures ongoing patient safety, regulatory adherence, and device integrity in an evolving threat landscape. Medcrypt’s services help manufacturers maintain regulatory cybersecurity compliance and safeguard device integrity against emerging threats after FDA approval.

Get post-market help now!

Cybersecurity incident response

Prepare for real-world threats with our Incident Response Readiness Review. We simulate incident response scenarios to test, refine, and validate your response plans—ensuring rapid containment, minimal impact, and protection of your company’s reputation.

Vulnerability management & patch strategy development

We'll work with you to establish robust processes for continuous monitoring of vulnerabilities and threats. This includes developing regulatory-compliant patching and update strategies to ensure the ongoing integrity of your medical devices.

Cybersecurity risk management

Assess your security posture, prioritize risks, and develop a strategic roadmap for continuous improvement. We help you align security initiatives with industry standards to enhance protection and resilience.

SBOM validation & monitoring

Automated Software Bill of Materials (SBOM) validation and monitoring to track and mitigate emerging vulnerabilities in third-party components.

Cybersecurity maturity assessment

Advance your security posture with a tailored assessment that benchmarks your security capabilities, identifies gaps, and provides a roadmap for improvement.

Secure development lifecycle (SDLC) integration

Our tailored cybersecurity trainings incorporating industry-leading best practices citing global regulatory guidances and standards. Medcrypt will educate your team in the critical cybersecurity elements to incorporate into your device lifecycle.

Cybersecurity incident response

Prepare for real-world threats with our Incident Response Readiness Review. We simulate incident response scenarios to test, refine, and validate your response plans—ensuring rapid containment, minimal impact, and protection of your company’s reputation.

Vulnerability management & patch strategy development

We'll work with you to establish robust processes for continuous monitoring of vulnerabilities and threats. This includes developing regulatory-compliant patching and update strategies to ensure the ongoing integrity of your medical devices.

Regulatory change management & compliance updates

Proactive tracking of evolving cybersecurity regulations, guidance and standards, including FDA and global requirements, with strategic guidance to keep your device security and documentation aligned with the latest compliance expectations.

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Helping our customers succeed

From startups to top enterprise device manufacturers, companies worldwide turn to Medcrypt. We work with organizations of all sizes to help secure their products.

"Medcrypt was very knowledgeable and with Medcrypt's help, our cybersecurity-related AINN responses were a slam dunk"

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.

"Medcrypt was very knowledgeable and with Medcrypt's help, our cybersecurity-related AINN responses were a slam dunk"

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
AJ Reiter

AJ Reiter

Director of Strategy and Organizational Transformation
Nick Atwell

Nick Atwell

Senior Manager of Cybersecurity
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.