MedCrypt GTM brain
Medcrypt provides cybersecurity compliance software and advisory services to medical device manufacturers preparing and maintaining FDA submissions.
category
Medical device cybersecurity compliancemarket profile
- text: Medical device manufacturers must assemble security evidence for premarket submissions and manage vulnerabilities after release.
- text: The product combines submission readiness, threat modeling, SBOM and vulnerability management with expert advice.
personas
- title: VP regulatory affairs at a medical device manufacturerpains:
- Cybersecurity evidence gaps may delay an FDA submission.
- Threat models, SBOMs and postmarket plans must be consistent and traceable.
- title: Product security leadpains:
- Maintaining software inventories and monitoring vulnerabilities across device lifecycles.
- Coordinating risk assessment and remediation with engineers and regulatory teams.
- title: Medical device engineering leaderpains:
- Security documentation and testing compete with product delivery.
- Small teams may lack specialist FDA cybersecurity expertise.
icp
- text: Medical device OEMs building connected or software-enabled devices for FDA review, from emerging manufacturers to large multi-product enterprises.
- text: Manufacturers with a product security, quality or regulatory function and ongoing postmarket obligations.
message pillars
- text: Identify gaps ahead of review.
- text: Combine tools with healthcare-specific expertise.
- text: Manage compliance throughout the device lifecycle.
objections
- objection: We have internal security and regulatory staff.response: Use the readiness check to identify specific documentation gaps and assess where reviewer expertise helps.
- objection: We need SBOM monitoring but not a full platform.response: The pricing page offers standalone Helm by discussion; confirm scope and pricing.
- objection: The subscription is expensive for one submission.response: Assess the annual per-product-line package against ongoing monitoring and included advisory hours, not just initial filing.
competitors
- name: Cybellumwebsite: https://cybellum.comwhy: Product security and SBOM tools for device manufacturers.
- name: MedSecwhy: Medical device cybersecurity consulting and testing across the lifecycle.
- name: Cybeatswhy: SBOM and software supply chain security for device makers.
keywords
- FDA medical device cybersecurity
- medical device SBOM software
- FDA cybersecurity submission readiness
- medical device threat modeling
- medical device vulnerability management
- FDA eSTAR cybersecurity
voice
- regulatory-specific and direct
- confident and pragmatic
signals
- text: A connected device manufacturer is preparing an FDA submission or addressing a cybersecurity deficiency letter.
- text: A device business is building its first SBOM and postmarket vulnerability program.
pricing
model: flat
starting price: $35,000 per product line per year
motion
hybridchannels
- webinars
- search
- industry partnerships
- sales
confidence
highFounders
- name: Mike Kijewskititle: Founderrole: Founder
- name: Eric Pancoasttitle: Founderrole: Founder