The futureof medical devices is secure by design

“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"