Services We Provide
In the dynamic world of Biotechnology, Trigon Cyber offers a range of specialized services to navigate the complex landscape. These services are designed to help biotech clients navigate the sector’s unique challenges and thrive in a highly regulated and evolving industry.
Navigating Regulatory Compliance
Focusing on the stringent requirements of the FDA Center for Devices and Radiological Health, Trigon Cyber provides expert guidance in compliance. This includes navigating regulatory guidance, submission contents, managing Device Master Records (DMR), and Design History Files (DHF), along with their implementation requirements.
Medical Device Product Development
Trigon Cyber supports the intricate process of medical device development. Their services encompass market analysis, general risk management, and adherence to the Systems Development Life Cycle, ensuring an integrated approach to both corrective and preventative actions.
Model-Based Systems Engineering (MBSE)
Trigon Cyber leverages MBSE for efficient design and development in biotech. They offer services in requirements traceability and conceptual modeling, vital for streamlined system creation.
Data Analytics & Bioinformatics
Addressing the increasing reliance on data in biotech, Trigon Cyber provides data analytics and bioinformatics services. These services focus on data-driven decision-making, AI-powered insights, and predictive modeling enhanced with advanced data visualization techniques.
Comprehensive Cybersecurity Solutions
Recognizing the critical need to protect sensitive biotech data, Trigon Cyber offers a wide array of cybersecurity services. These include risk assessment, network and endpoint security, data encryption, access control, and compliance with biotech-specific regulations. Additionally, they offer medical device security, penetration testing, and continuous monitoring services.
