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Prognosys Medical Systems, a subsidiary of Molbio Diagnostics, recently achieved EU MDR certification for its medical imaging portfolio. This significant milestone allows the company to expand its reach into globally regulated markets. Consequently, the certification highlights India's growing capability in the medtech sector. Furthermore, it ensures adherence to rigorous international standards for safety and clinical performance.
The certification covers the ProRad portfolio, which includes both fixed and mobile digital imaging platforms. Because these systems meet European Union standards, they are now ready for deployment in diverse healthcare settings worldwide. Moreover, this development aligns with Molbio’s strategy to integrate molecular diagnostics with radiological tools. As a result, healthcare providers can offer faster and more decentralized disease detection services.
Sriram Natarajan, CEO of Molbio Diagnostics, emphasized that this achievement reflects the potential of \"Make in India\" solutions. Additionally, the ProRad solutions focus on improving diagnostic access. Since the certification was issued by TÜV SÜD, it confirms the highest level of quality management. Consequently, Indian medical technology is becoming increasingly competitive on the global stage.
Q1: What is the significance of the EU MDR certification for Prognosys?
The EU MDR certification ensures that the company’s imaging products meet strict safety and quality regulations required for the European market and other global regions.
Q2: How does this benefit the ProRad portfolio?
This milestone allows the ProRad digital imaging solutions to be deployed in global healthcare programs, improving access to diagnostic tools in various settings.
Disclaimer: This content is for informational and educational purposes only. It does not constitute medical advice or replace professional judgment. Refer to the latest local and national guidelines for clinical practice.
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Prognosys Medical Systems, a Molbio subsidiary, received EU MDR certification for its digital radiology portfolio, facilitating global market expansion....
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