Molbio Diagnostics, a global diagnostics company, announced that its subsidiary, Prognosys Medical Systems, has secured the European Union Quality Management System (QMS) certification under Regulation (EU) 2017/745 (EU MDR) for its medical imaging portfolio.
The certification, issued by TÜV SÜD Product Service GmbH, marks a significant milestone in Molbio’s journey to expand into globally regulated markets. It reflects the company’s commitment to building medical technologies that meet international benchmarks for safety, quality, and clinical performance.
Prognosys Medical Systems specializes in digital imaging solutions, including fixed and mobile platforms designed to improve diagnostic access across diverse healthcare settings. This development further strengthens Molbio’s integrated diagnostics strategy, bringing together molecular and radiological capabilities to enable faster, more decentralized and accurate disease detection.
The EU MDR QMS certification issued by TÜV SÜD Product Service GmbH covers key imaging systems within the PRORAD portfolio, including:
- Digital Radiology (DR) systems for generating static diagnostic images of the human body
- Mobile C-arm systems for real-time imaging during surgical and interventional procedures
- Mobile X-Ray Systems for use in operating theatre, emergency room, mobile vans, etc
- Ultraportable digital X-ray systems for use in emergency and remote healthcare environments
This milestone signifies that the ProRad portfolio meets applicable international quality standards, reinforcing its adherence to established regulatory and compliance requirements across relevant markets and healthcare programs. For healthcare providers in India, this enables access to globally validated, reliable diagnostic technologies. For Indian patients, it translates into faster diagnosis, improved clinical outcomes, and enhanced safety standards.
“This certification is not only significant for Molbio, but a moment of pride for Indian innovation”, said Sriram Natarajan, Executive Director & CEO, Molbio Diagnostics. “It demonstrates that India can create ‘Make in India’ solutions that stand shoulder-to-shoulder with the best in global med-tech”.
Calling it a defining milestone, Krishna Prasad Vajapeyam, President and Founder of Prognosys Medical Systems, added, “Achieving one of the world’s most rigorous regulatory certifications is a testament to our engineering excellence and unwavering focus on patient safety and clinical performance. With EU MDR certification, PRORAD is well-positioned to serve healthcare providers globally with the reliability and precision that define our approach.”
Reinforcing its clinical relevance, internationally trained orthopaedic surgeon Dr Darshan Angadi said, “Imaging forms the backbone of clinical decision-making in orthopaedics. ProRad systems have been useful in providing timely access to X-ray imaging, particularly in emergency and high-volume settings where speed and clarity are important. These global recognitions and validations provide an added layer of confidence in the minds of patients regarding the reliability and consistency of the imaging systems being used. From a practitioner’s standpoint, any development that supports standardized quality and dependable performance is a positive step toward improving overall patient care”.
The certification aligns PRORAD with international quality standards in medical device manufacturing, reinforcing its role in advancing accessible, high-quality diagnostic care across global markets.