Medical Certification Services

We support manufacturers and developers of health wearables in obtaining medical license approvals for fitness trackers, smartwatches, biosensors, and other wearable health monitoring devices.

Our services include:

• Regulatory pathway assessment and classification guidance
• Medical device license application preparation and submission
• Technical documentation and clinical evidence compilation
• Quality management system (QMS) alignment with medical standards
• Risk management and safety documentation (ISO 14971)
• Pre-market review and approval coordination
• Post-market surveillance and compliance maintenance
• Label and packaging compliance verification

We assist digital mental health platforms, telepsychiatry applications, and behavioral health software in securing medical licenses and regulatory approvals for mental health services delivery.

Our services include:

• Digital therapeutics (DTx) classification and licensing strategy
• Clinical validation and evidence generation support
• Data privacy and patient confidentiality compliance (HIPAA, GDPR)
• Software as a Medical Device (SaMD) regulatory framework alignment
• Clinical evaluation reports and performance assessments
• Telehealth and telemedicine regulatory compliance
• Cybersecurity and information security requirements (ISO 27001)
• Ongoing regulatory updates and license renewals

We provide regulatory support for men's health applications covering wellness monitoring, condition management, telemedicine consultations, and specialized health tracking platforms.

Our services include:

• Medical app classification and regulatory pathway determination
• License application preparation for health and wellness apps
• Clinical claims validation and substantiation
• Medical device software lifecycle management (IEC 62304)
• Usability and human factors engineering documentation
• Interoperability and data integration compliance
• Marketing and advertising compliance review
• Continuous compliance monitoring and regulatory intelligence

We facilitate efficient communication and real-time collaboration through dedicated WhatsApp groups, ensuring quick responses, document sharing, and streamlined coordination throughout the certification process.

Collaboration benefits:

• Dedicated WhatsApp group for your certification project
• Real-time updates on application status and regulatory developments
• Quick clarifications and expert guidance on demand
• Secure document sharing and review cycles
• Direct access to regulatory specialists and technical advisors
• Milestone tracking and deadline management
• Rapid response to regulatory authority queries
• Continuous support throughout the approval journey

Through our strategic collaboration with SecDelta, we provide comprehensive technical and regulatory solutions tailored to the unique requirements of digital health platforms and medical devices.

Partnership advantages:

• Enhanced cybersecurity and data protection frameworks
• Technical architecture review for medical software compliance
• Information security management system (ISMS) implementation
• Penetration testing and vulnerability assessments
• Secure development lifecycle integration
• Cloud infrastructure compliance (AWS, Azure healthcare frameworks)
• Third-party risk assessment and vendor management
• Incident response planning and business continuity