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Don't Let Cybersecurity Be Your Bottleneck

Secure Market Access and Drive Revenue with Medcrypt Product Security Intelligence.

Smarter Investments. Measurable ROI.

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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.

Challenge

In today's medical device landscape, cybersecurity isn't just an IT concern - it's a patient safety imperative and a critical driver of procurement decisions. The stakes have never been higher:

Market Access at Risk

Market
Access at Risk

A staggering 46% of healthcare organizations have declined medical device purchases due
to cybersecurity concerns.
Don't let your innovative device be shut out of the market before it even begins.

Patient Care Compromised

Patient Care Compromised

22% of healthcare organizations have experienced cyberattacks impacting medical devices, with 75% of those incidents directly affecting patient care. These aren't hypothetical risks; they lead to delayed diagnoses, extended patient stays, and even patient transfers.

Rising Budgets, Lagging Confidence

Rising Budgets, Lagging Confidence

While 75% of organizations increased their medical device cybersecurity budgets in the past year, only 17% feel extremely confident in their ability to detect and contain attacks on medical devices. This gap highlights a critical need for more effective solutions. 

Benchmarking

Medcrypt's Product Security Intelligence Platform

Specifically designed to address these urgent challenges and turn cybersecurity into your competitive advantage. Our solution empowers you to:

Accelerate Time to Market: By identifying and addressing security gaps early, you can avoid costly delays and ensure your product reaches patients faster. This directly tackles the "tight timelines" challenge faced by manufacturers.
Make Smarter Investments with Measurable ROI: Our platform helps you quantify the dollar risk of cybersecurity debt, allowing you to invest resources where they deliver the highest measurable value. No more fragmented implementations or guesswork on where to prioritize.
Gain Buyer Trust and Command a Premium: Healthcare buyers are actively seeking devices with built-in cybersecurity, with 60% prioritizing these protections when selecting vendors. Furthermore, an overwhelming 79% are willing to pay a premium for advanced runtime protection or built-in exploit prevention —with 41% willing to pay 5-15% more for enhanced security! By leveraging Medcrypt, you demonstrate a proactive approach that aligns with evolving procurement prerequisites and regulatory mandates.
Establish and Track Maturity: Quickly assess your current cybersecurity posture, benchmark across your organization and industry, and track your security maturity over time, preparing for future improvements and supporting long-term budgeting.




Built for lifecycle impact, Medcrypt aligns with premarket and postmarket regulatory approval benchmarks, ensuring you meet global customer and regulatory expectations.
Don't let cybersecurity be an afterthought that limits your market potential. Partner with Medcrypt to ensure your medical devices are secure by design, expediting your go-to-market process and building lasting trust with healthcare providers.

Our proven track record

Every customer who needed help navigating cybersecurity documentation requirements for the FDA 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.

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

Free Resources

Expert content to help you through your regulatory submission journey.

Download the full case study

Get all the details, data, and in-depth analysis by downloading our full case study.