Our Experience in Cybersecurity

MCRA's deep therapeutic expertise in the medical device industry enables us to integrate our core services to create a customized approach catered to our clients' need. MCRA's CRO, Healthcare Compliance, Regulatory Affairs, Quality Assurance, Reimbursement, Digital Health, and Cybersecurity are aligned to support our clients' vision to improve medical device performance and increase patient access.

Cybersecurity Services

Our Expertise

  • Cybersecurity Risk Assessment and Strategy
  • Quality management system compliance
  • HIPAA & GDPR Compliance
  • Device Cybersecurity Plan
  • Organizational Cybersecurity Plan 

Advising & Services

  • Device security risk assessment
  • Design control remediation
  • Security gap analysis
  • Threat modeling

Product & Outreach

  • Cybersecurity software products
  • Risk assessment
  • Risk management
  • Subscription assessment services
  • Internal & external workshops

Cost of a Data Breach

Cost of a Data Breach Statistics

Source: Cost of a Data Breach Report highlights IBM

 

Digital Health & Cybersecurity

Our Experience in Digital Health

Our team had industry-leading experience with advanced first-in-class digital health medical devices. MCRA offers top quality advisory and representation for companies navigating the evolving regulatory framework for digital health medical devices.

MCRA's Digital Health services include:

  • Full-service regulatory program support
  • Strategy and advisory
  • Digital health regulatory policy assessment and advisory
  • Test plan development and review
  • Documentation development and review
  • Regulatory submission development and review
  • Risk assessment development and review
  • Market pathway strategy