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. When it comes to cybersecurity for medical devices, our solutions offer the highest levels of protection.

Pie Chart

Cybersecurity Services

Our Expertise

  • Cybersecurity Strategy for Medical Devices and Risk Assessment
  • HIPAA & GDPR Compliance
  • Medical Device Cybersecurity Plan
  • Organizational Cybersecurity Plan

Advising & Services

  • Device Security Risk Assessment
  • Design Control Remediation
  • Security Gap Analysis
  • Threat Modeling
  • 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 digital health team has industry-leading experience with advanced, first-in-class digital health consulting for medical devices. MCRA offers top quality advisory services 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