Mumbai: Molbio Diagnostics has announced that its digital radiology subsidiary, Prognosys Medical Systems, has received the European Union Quality Management System (QMS) certification under Regulation (EU) 2017/745 (EU MDR) for its medical imaging portfolio.
The certification, granted by TÜV SÜD Product Service GmbH, marks a key milestone in Molbio’s expansion into regulated global markets. It underscores the company’s adherence to internationally recognized standards for safety, quality, and clinical performance.
Prognosys Medical Systems develops digital imaging technologies, including fixed and mobile platforms aimed at improving access to diagnostics across varied healthcare environments. The certification strengthens Molbio’s integrated diagnostics strategy, combining molecular diagnostics with radiology to enable faster, decentralized, and more accurate disease detection.
The EU MDR QMS certification covers major systems within the PRORAD portfolio, including digital radiology systems, mobile C-arm systems used in surgical procedures, mobile X-ray units for emergency and operating settings, and ultraportable X-ray devices designed for remote and critical care use.
According to Molbio, the certification validates that the PRORAD portfolio meets stringent international quality and regulatory standards. This is expected to enhance trust among healthcare providers and improve patient access to reliable diagnostic technologies, particularly in India and other emerging markets.
Sriram Natarajan, Executive Director and CEO of Molbio Diagnostics, described the achievement as a moment of pride for Indian innovation, highlighting the capability of “Make in India” solutions to compete with global med-tech leaders.
Krishna Prasad Vajapeyam, President and Founder of Prognosys Medical Systems, termed the certification a defining milestone, emphasizing the company’s focus on engineering excellence, patient safety, and clinical performance. He added that the certification positions the PRORAD portfolio strongly for global deployment.
Commenting on the clinical impact, orthopaedic surgeon Dr Darshan Angadi noted that high-quality imaging is critical for timely and accurate decision-making, particularly in emergency and high-volume settings. He added that global validation enhances confidence in the reliability and consistency of such imaging systems.
The certification aligns PRORAD with global medical device manufacturing standards, reinforcing its role in advancing accessible and high-quality diagnostic care worldwide.