The Medcrypt difference:
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.
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.
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.
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.
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.
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.
In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the responseprocess effectively.
Advance your security posture with detailed assessments that benchmark your current cybersecurity capabilities against FDA expectations and industry best practices.
Our former FDA reviewers conduct deep-dive evaluations of your security architecture, processes, and documentation, identifying specific gaps that could delay regulatory approval.
Get a detailed improvement roadmap with prioritized recommendations, timeline estimates, and resource requirements to achieve FDA-ready security maturity before submission.
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
In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the responseprocess effectively.
Our experts help you integrate SBOM generation, vulnerability scanning, and security testing considerations into your development lifecycle, ensuring continuous security validation throughout development.
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.
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.
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.
Medcrypt boasts the only Services team with former FDA reviewers who will ensure your success — 100% guaranteed.
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.
We help you prioritize threats based on patient safety impact, exploitability, and regulatory requirements using proven methodologies.
We assess your security posture, help you prioritize risks, and develop a strategic roadmap that aligns security investments with industry standards and regulatory requirements.
Automated SBOM validation and continuous monitoring to track and mitigate emerging vulnerabilities in third-party components, helping ensure compliance with regulatory requirements.
Stay ahead of rapidly evolving cybersecurity regulations with our comprehensive change management services that translate new requirements into actionable steps.
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.
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.
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.
Accelerate FDA approval with expert guidance from those who know the process inside and out.
Get pre-market help now!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.
In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the response process effectively.
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.
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
Advance your security posture with a tailored assessment that benchmarks your security capabilities, identifies gaps, and provides a roadmap for improvement.
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.
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.
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.
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.
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.
Automated Software Bill of Materials (SBOM) validation and monitoring to track and mitigate emerging vulnerabilities in third-party components.
Advance your security posture with a tailored assessment that benchmarks your security capabilities, identifies gaps, and provides a roadmap for improvement.
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.
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.
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.
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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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"
“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!”
"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"
"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.”
"Medcrypt's structured approach to document review was very helpful. We liked their guidance and enjoyed working with the Medcrypt team."
"We were thinking it was going to take a month to get an SBOM and Medcrypt provided it in 3 days"
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
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.
We are FDA and medical device experts helping healthcare technology companies build products that are secure by design.
Naomi is a regulatory, compliance, and standards expert. She employs gap analyses, proposes mitigation strategies, and optimizes cybersecurity frameworks to address risk and uncertainty for device commercialization and to meet regulatory requirements and guidelines. Naomi has 20+ years of systems engineering experience.
Prior to Medcrypt, she was a premarket reviewer and consumer safety officer in CDRH for 6+ years, focusing on software, interoperability, and cybersecurity for connected diabetes devices. Her industry leadership and strategic direction include crafting standards and recommended practices for wireless diabetes device security, managing postmarket triage for cybersecurity vulnerability disclosure. She holds an MS in Electrical and Computer Engineering from Carnegie Mellon University and is a Certified Quality Auditor.
Seth has 10 years of medical device experience and provides strategic direction for cybersecurity products and services for the regulated device market.
Prior to Medcrypt, he spent 8 years at the FDA, architecting technology policy and laws that impact software-enabled medical devices, including the FDA’s medical device cybersecurity policies. His industry leadership and strategic direction extends to several high-profile industry frameworks including the Joint Security Plan (HSCC), MITRE’s Rubric for Applying CVSS to Medical Devices, and MDIC’s Playbook for Threat Modeling Medical Devices. He has authored several medical device cybersecurity papers and won several information security awards. He holds a PhD in Chemistry from Indiana University.
AJ specializes in enterprise digital transformation, program development, continuous process improvement, and cybersecurity. He assesses organizational security and implements actionable transformation plans and services to achieve executive targets.
Prior to Medcrypt, he spent five years doing management consulting, providing comprehensive business transformation services to Fortune 500 clients in various industries, including Pharmaceuticals, Defense, Consumer Packaged Goods, and Medical Devices. He has a BS in Economics from Georgetown University, where he captained the 4x national champion Georgetown Sailing Team.
Nick is a cybersecurity expert with extensive experience in PKI, Risk Management, and regulatory compliance. At MedCrypt, he focuses on aligning security architectures and Quality Management Systems (QMS) with FDA and industry standards while ensuring solutions are practical and user-friendly. Previously, Nick led PKI initiatives at Cerner, managing enterprise cryptographic infrastructure and implementing automation to streamline security processes. His work emphasizes both enhancing security posture and delivering solutions that balance compliance with usability.
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Medcrypt’s own FDA expert, Naomi Schwartz, discusses what the new policy means for MDMs.
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Get your secure medical devices to market on or even ahead of schedule, with peace of mind.
