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 helpOptimize 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.
Get immediate guidance to navigate your response process effectively.
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.
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.
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.
“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.
Medcrypt’s own FDA expert, Naomi Schwartz, discusses what the new policy means for MDMs.
Watch videoGet your secure medical devices to market on or even ahead of schedule, with peace of mind.