ISO 13485:2016 – Quality Management System for Medical Devices

Bigsun Technologies Private Limited has been officially awarded the ISO 13485:2016 certification for its Quality Management System (QMS) specific to medical devices. This globally recognized standard is an essential milestone for organizations involved in the design, development, production, installation, and servicing of medical devices, including related services and software components.

What is ISO 13485:2016?

ISO 13485:2016 is an internationally accepted quality management system standard developed specifically for the medical device industry. It outlines a rigorous framework for ensuring consistent design, development, production, installation, and delivery of medical device-related products that consistently meet regulatory and customer requirements.

Unlike ISO 9001, which is a generic quality management standard, ISO 13485 is tailored for medical device manufacturers and their suppliers, emphasizing risk management, documentation control, traceability, and regulatory compliance throughout the product lifecycle.

Scope of Certification for Bigsun Technologies Private Limited

The certification awarded to Bigsun Technologies Private Limited covers:

Healthcare and Hospital Information System (HIS) products/platforms
Application development, installation, and support
Development and deployment of APIs (application program interfaces)
Use of Artificial Intelligence (AI), with or without database integration
Maintenance of both medical and non-medical records for clients

This certification ensures that our solutions—especially in the healthcare IT sector—adhere to international best practices for quality, safety, and reliability.