Secure Your First Medical Device Clearance - Without Cybersecurity Holding You Back

From idea to FDA approval, we help startups build in cybersecurity from day one.

You're prepping your first submission and heard that cybersecurity documentation is now a requirement. But you don’t have a security team, and compliance seems overwhelming.

Gradient triangle vector

Preparing for a regulatory submission?

Get a complimentary readiness assessment for FDA, EU/MDR, or Health Canada regulatory approval. Enter your email below to get started for free.

medcrypt logo

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.

FDA Arrows

How Medcrypt Helps:

With the increasing threat of cyberattacks, the FDA has heightened its focus on the cybersecurity resilience of medical devices. To avoid costly delays, eliminate rejections, and reduce post-market repercussions, your submission needs to demonstrate:

Pre-built security documentation aligned with FDA requirements
Advisory on 510(k), Pre-Market Approval (PMA), Predetermined Change Control Plans (PCCPs), European Union Medical Device Regulations (EU MDR) and Health Canada submissions
Cryptography and secure provisioning tools tailored to startups
Advisory support that scales with your development milestones
100% submission success rate for FDA cybersecurity documentation

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
Ira Owens

Ira Owens

Director of Cybersecurity

Free Resources

Expert content to help you through your regulatory submission journey.