How We Work
We offer comprehensive capabilities that enable faster, safer, and more efficient development of medical devices. From end-to-end product development to infrastructure, talent, and operational models, we provide the complete ecosystem required to bring innovative MedTech solutions to life.
Engagement Models
We offer flexible engagement models to match your delivery and compliance needs:
Fixed-Price
Best for well-defined scopes with predictable timelines and costs.
Time & Materials
Ideal for evolving requirements and agile development cycles.
Dedicated Team
A long-term extension of your team focused on continuous delivery and domain expertise and a leading global capability center (GCC).
QMS-aligned Delivery Processess
ISO 13485 – Quality Management Systems
We align our delivery practices with ISO 13485 principles to ensure controlled processes, consistent quality, and audit-ready documentation across engagements.
IEC 62304 – Medical Device Software Lifecycle
Our software development follows a structured, risk-based lifecycle aligned with IEC 62304, ensuring traceability from requirements through verification and maintenance.
ISO 14971 – Risk Management
Risk management is embedded into our delivery approach, ensuring hazards are identified, evaluated, controlled, and documented throughout development.
IEC 62366 – Usability Engineering for Medical Devices
We align our design and development practices with IEC 62366 principles to ensure safe, effective, and user-centered medical device interfaces, reducing use-related risks and supporting regulatory compliance.
IEC 60601-1 – Medical Electrical Equipment Safety
We align our development and validation practices with IEC 60601-1 principles to ensure the basic safety and essential performance of medical electrical equipment, supporting regulatory approval and patient safety.
HIPAA & GDPR – Data Privacy and Security
We apply data protection and privacy principles aligned with HIPAA and GDPR to safeguard sensitive healthcare and patient data.
Get in Touch
Ready to experience the difference? Contact us today to learn how we can support your medical device development needs.