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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.
Click here for cybersecurity strategy helpNavigate 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.
Prepare for real-world threats with our Incident Response Tabletop Exercises. 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 SBOM validation and monitoring to track and mitigate emerging vulnerabilities in third-party components.
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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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"
“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.
Ira is a expert cybersecurity professional with over 18 years experience. Having led organizations, projects, and initiatives in the federal government and private sector, he brings a multitude of medical device, IoT, regulatory, and cybersecurity operations expertise. Ira has held senior manager and director positions for a Top 40 medical device manufacturer. He has extensive knowledge of the best practices and challenges associated with risk management, vulnerability management, and incident response. He is also well versed in ensuring regulatory compliance with FDA, EU MDR, and other notified bodies.
Ira currently holds ISC2’s Certified Information Systems Security Professional (CISSP) and ISACA’s Certified Information Security Manager (CISM) and CompTIA’s Sec+ cybersecurity certifications. He also holds a M.S. in Cybersecurity.
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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.
