As India’s medical technology sector expands its manufacturing and innovation capabilities, the need for robust quality and regulatory systems is gaining greater importance. Addressing this requirement, the Medtech Quality and Communications Institute (MQCI), an initiative at the Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam, has certified 100 Lead Auditors for the MedTech sector in collaboration with certified bodies.
The initiative is aimed at strengthening specialised professional expertise in quality management systems, auditing and regulatory compliance across the medical technology industry. Regulatory compliance is an integral part of medical device manufacturing, encompassing systems and processes that help organisations maintain consistent quality and meet applicable standards.
While regulatory frameworks establish the requirements for medical device manufacturers, their effective implementation also depends on professionals capable of assessing quality systems, identifying gaps and supporting continuous improvement. MQCI’s Lead Auditor programme has been designed to strengthen this professional capability by providing specialised training in quality management system auditing and compliance assessment.
The certification of 100 Lead Auditors represents an effort to create a specialised pool of professionals who can support MedTech organisations in strengthening their quality and regulatory practices. The initiative is particularly relevant as Indian medical technology companies increasingly seek to meet international quality expectations and expand their participation in global markets.
Dr Jitendra Sharma, Non-Executive President, MQCI, said, “As Indian MedTech companies move towards greater global participation, regulatory understanding and quality expertise become increasingly important. MQCI was established to help build this specialised capability, and the certification of 100 Lead Auditors reflects the growing professional foundation needed to support the sector.”
Prof Bejon Kumar Misra, Chairman, MQCI, said, “Quality in medical devices is ultimately about patient safety and consumer trust. Regulations and standards provide the framework, but their real value is realised only when they are consistently implemented, independently assessed and continuously improved. By creating a professional pool of trained Lead Auditors, MQCI is helping build a stronger culture of quality and accountability across India’s MedTech ecosystem. The certification of 100 Lead Auditors is therefore not merely a milestone in professional capacity building; it is a step towards ensuring that medical devices made in India earn the confidence of patients, healthcare professionals and markets in India and across the world.”
The programme is expected to support organisations in translating regulatory requirements into consistent operational practices through stronger auditing and quality management capabilities. Developing professionals with specialised expertise in these areas can also contribute to the adoption of globally aligned quality systems as Indian MedTech companies expand their presence in international markets.
The initiative reflects AMTZ’s broader focus on developing capabilities required for a quality-driven and globally aligned MedTech ecosystem. Alongside professional capacity building, AMTZ continues to support manufacturing innovation and technology development aimed at strengthening India’s medical technology ecosystem.
