Quality You Can Trust: ICMED 13485 Plus, CE-Certified, BIS Certified Medical Device manufacturers from India

Globally compliant. Nationally trusted. Clinically reliable.

At AVI Healthcare Pvt Ltd, quality is the cornerstone of everything we do. As a leading medical device manufacturer in India, we specialize in the design and production of a wide range of NICU and ICU equipment — including infant warmers, phototherapy units, Bubble CPAP systems, ICU ventilators, and transport incubators.

We are proud to be the first Indian manufacturer to receive the ICMED 13485 Plus product certification — a mark of quality aligned with global standards and comparable to the European CE conformity. Our medical devices are designed and manufactured to support neonatal and critical care with precision, durability, and safety.

Our commitment to quality is further strengthened through BIS certification (Bureau of Indian Standards) for applicable products, ensuring compliance with India’s national regulatory and safety requirements for medical devices.

Our Quality Management System (QMS) is fully compliant with:

• EN ISO 13485:2016 – International standard for medical device quality systems
• EU MDR 2017/745 – European regulatory framework
• IMDR 2017 – Indian Medical Device Rules
• BIS standards (as applicable) – National conformity and safety requirements

We maintain strict quality control and assurance practices across the entire product lifecycle — from design and development to production, testing, and post-market surveillance. Every device undergoes rigorous testing in accordance with EN/IEC and ISO safety standards to ensure maximum reliability and patient safety.

Having successfully transitioned from CE under MDD to compliance with EU MDR, we demonstrate our ongoing commitment to regulatory excellence, continuous improvement, and global market readiness.