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
- HIPAA & GDPR Compliance
- Device Cybersecurity Plan
- Organizational Cybersecurity Plan
Advising & Services
- Device security risk assessment
- Design control remediation
- Security gap analysis
- Threat modeling
- Internal & external workshops
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