AMTZ certifies 100 Lead Auditors as India’s medical device sector expands

The Andhra Pradesh MedTech Zone (AMTZ) has certified 100 professionals as Lead Auditors for the medical device sector, addressing a growing need for expertise in quality systems and regulatory compliance as Indian manufacturers look to global markets.

The certification was carried out by the MedTech Quality and Communications Institute (MQCI), an AMTZ initiative, in collaboration with certification bodies.

The programme comes as India’s medical technology sector expands its manufacturing base and develops products for markets that require compliance with international quality standards.

Lead Auditors assess quality management systems, identify compliance gaps and check whether processes follow prescribed standards. The latest certification brings the number of MQCI-trained personnel to 100.

The programme aims to create a pool of professionals who can support manufacturers with quality audits and compliance assessments as they seek to meet overseas regulatory requirements.

Dr Jitendra Sharma, Non-Executive President of MQCI, said: “As Indian MedTech companies move towards greater global participation, regulatory understanding and quality expertise become increasingly important. The certification of 100 Lead Auditors reflects the growing professional foundation needed to support the sector.”

Prof Bejon Kumar Misra, Chairman of MQCI, said quality systems in medical devices have a direct bearing on patient safety and consumer confidence.

“Regulations and standards provide the framework, but their real value is realised only when they are consistently implemented, independently assessed and continuously improved,” he said.

MQCI is part of AMTZ’s broader efforts to build capabilities in manufacturing, quality and technology, and to develop an ecosystem for production and innovation.