New Delhi: Molbio Diagnostics announced that its subsidiary Prognosys Medical Systems has secured the European Union Quality Management System certification under Regulation (EU) 2017/745 (EU MDR) for its medical imaging portfolio.
The certification, issued by TÜV SÜD Product Service GmbH, marks company to expand into globally regulated markets and reflects its adherence to international standards for safety, quality, and clinical performance.
Prognosys Medical Systems develops digital imaging solutions, including fixed and mobile platforms aimed at improving diagnostic access across diverse healthcare settings. The development supports Molbio’s integrated diagnostics strategy by combining molecular diagnostics with radiological imaging to enable faster and more decentralised disease detection.
According to the company, the certification indicates that the ProRad portfolio meets international quality and regulatory standards required for deployment across global healthcare programs.
“This certification is not only significant for Molbio but also reflects the growing capability of Indian medtech innovation. The milestone demonstrates the potential of ‘Make in India’ solutions in global med-tech markets.,” said Sriram Natarajan, Executive Director and CEO, Molbio Diagnostics.
