KIHT Certification Services (KCS) successfully conducted an intensive five-day training programme on ISO 13485:2016 certification for medical devices. The training was held in two batches from 8–12 September and 15–19 September 2025 at the AMTZ Campus, Visakhapatnam, with funding support from the Biotechnology Industry Research Assistance Council’s (BIRAC) National Biopharma Mission (NBM). The initiative focused on equipping participants with practical skills in implementing and auditing quality management systems.
The programme was designed to strengthen quality frameworks within India’s medical technology sector, ensuring higher standards of patient safety and enhancing global competitiveness. By developing a pool of skilled professionals trained in certification and regulatory processes, the initiative supports the country’s goal of building a robust, internationally compliant medtech ecosystem.
KIHT Certification Services (KCS) is a specialised organisation dedicated to advancing quality and regulatory standards in India’s medical technology and life sciences sector. It offers certification, auditing, and training services that help manufacturers, startups, and healthcare organisations meet global compliance requirements such as ISO 13485:2016. By building capacity and providing hands-on guidance, KCS plays a vital role in improving quality management systems, fostering innovation, and enabling Indian medtech companies to compete effectively in international markets.
Andhra Pradesh MedTech Zone (AMTZ) is India’s premier medical device manufacturing park, located in Visakhapatnam. Spread across a state-of-the-art campus, AMTZ provides world-class infrastructure, including manufacturing units, R&D laboratories, testing and calibration centres, and regulatory support facilities.
It serves as a one-stop hub for medical technology innovation, reducing manufacturing costs and import dependency while accelerating product development and time-to-market. AMTZ has emerged as a key enabler in positioning India as a global leader in affordable and high-quality medical devices.
