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

Globally compliant. Nationally trusted. Clinically reliable.

At AVI Healthcare Pvt. Ltd., quality is embedded in every stage of our operations—from product design and development to manufacturing, testing, and post-market support. As a leading medical device manufacturer in India, we design and manufacture a comprehensive range of NICU equipment such as Infant Warmers, Phototherapy Units, Transport Incubators, Advance respiratory care devices like ICU ventilators, Bubble CPAP units that meet the highest standards of safety, performance, and reliability.

We are proud to be the first Indian manufacturer to receive the ICMED 13485 Plus product certification —  a nationally recognized certification scheme developed in alignment with global regulatory frameworks. In addition, Our ICU Ventilator is among the first Indian-manufactured ventilators to achieve CE certification under the European Medical Device Regulation (EU MDR 2017/745), reflecting our commitment to global quality, safety, and regulatory excellence. For applicable devices, AVI Healthcare also holds BIS certification, demonstrating compliance with India’s national regulatory and safety requirements for medical devices.

Our medical devices are designed and manufactured to support neonatal and critical care with precision, durability, and safety. Our Quality Management System is established and maintained in accordance 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 medical device undergoes comprehensive inspection, functional verification, and applicable electrical safety and performance testing in accordance with relevant EN/IEC 60601 and ISO safety standards before release.

Our successful transition from CE certification under the Medical Device Directive (MDD 93/42/EEC) to compliance with the European Medical Device Regulation (EU MDR 2017/745) reflects our continued commitment to regulatory excellence, continuous improvement, and global market access.

Quality at AVI Healthcare is not limited to regulatory compliance—it is a commitment to delivering safe, reliable, and clinically effective medical devices that healthcare professionals can trust every day.