IEC 62304:2006 – Medical Device Software Life Cycle Processes and Software Validation

Bigsun Technologies Private Limited has been successfully assessed and certified as compliant with the IEC 62304:2006 international standard for Medical Device Software – Software Life Cycle Processes and Software Validation This certification signifies our unwavering commitment to high-quality, safe, and regulatory-compliant software development, especially within the healthcare and medical technology domain.

What is IEC 62304?

IEC 62304:2006 is the globally recognized standard that defines the life cycle requirements for the development of medical software and software integrated into medical devices. It sets a structured framework for processes, activities, and tasks necessary throughout the software life cycle — from conception, risk management, design, development, verification, validation, deployment, through to maintenance and problem resolution.

This standard is mandated or referenced by various global regulatory bodies, including the FDA (U.S.), EMA (Europe), and other medical regulatory authorities worldwide.

Scope of Certification at Bigsun Technologies Private Limited

The IEC 62304 compliance scope at Bigsun Technologies Private Limited includes:

• Development of Healthcare and Hospital Information System
• Application development, installation, and support for software products, with a focus on API integration and AI-powered solutions.
• Software with or without database components, aiding in medical and non-medical records management.
• Support and compliance for software used in or with medical devices, ensuring reliability, traceability, and validation throughout the product lifecycle.