Operon Strategist

Nanomaterials in Medical Devices

Nanomaterials in Medical Devices: A Smart Guide to Biocompatibility

Introduction Nanotechnology has revolutionized the healthcare industry, offering breakthrough solutions in diagnostics, drug delivery, and implantable devices. At the heart of these innovations are nanomaterials in medical devices, enabling enhanced functionality, precision, and performance. However, as these materials integrate deeper into medical device design and manufacturing, one crucial factor demands attention — biocompatibility. Whether you […]

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MedTech

India swiftly emerging as global MedTech powerhouse; to grow at 12%

India is swiftly establishing itself as a major global player in the medical technology (MedTech) manufacturing sector. With the global healthcare landscape seeking more diversified and resilient supply chains, India is becoming a preferred destination for innovation, large-scale production, and cost-effective medical device solutions.  The Indian MedTech market, currently valued at USD 12 billion in

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Sterile Medical Devices

How Cleanrooms Play a Major Role in Manufacturing Sterile Medical Devices

Manufacturing Sterile Medical Devices: Key Processes, Cleanroom Requirements & Safety In the highly regulated world of medical device production, ensuring product sterility isn’t just a best practice — it’s a mandatory requirement. Cleanrooms play a crucial role in maintaining the controlled environments necessary for manufacturing sterile medical devices, safeguarding patient health, and meeting global regulatory

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Medical Device Sterilisation

CDSCO Relaxes Loan Licence Rule for Medical Device Sterilisation

Regulatory Update Brings Flexibility for Medical Device Sterilisation Outsourcing The Central Drugs Standard Control Organisation (CDSCO) has announced a significant regulatory relaxation for medical device manufacturers in India. As per the updated directive, manufacturers can now outsource the sterilisation of medical devices to third-party facilities without obtaining a loan licence, provided the facility holds a

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Medical Device Manufacturing in Greater Noida to Be India’s Largest

UP Government Launches Scheme to Boost Medical Device Manufacturing in Greater Noida

YEIDA Launches Plot Allocation Scheme for Medical Device Units The Uttar Pradesh government has introduced a new initiative aimed at promoting medical device manufacturing in Greater Noida, according to an official statement released on Tuesday. Under this initiative, the Yamuna Expressway Industrial Development Authority (YEIDA) has unveiled a scheme to allocate 21 industrial plots in

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Medical Device Labeling

The Future of Medical Device Labeling: Global Trends and Innovations

As the global medical device industry advances, labeling is no longer just a regulatory formality — it is becoming a strategic asset. The future of medical device labeling lies in digitalization, smart packaging, AI-powered personalization, and global regulatory harmonization.  For medical device manufacturers in India and across the globe, embracing these trends is essential to

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Process Validation in Medical Device

Process Validation in Medical Device Manufacturing: New Expectations and Compliance (2025 Guide)

As the medical device industry faces stricter global regulations in 2025, the importance of the process of validation in medical devices continues to grow. Medical device manufacturers must now prove — with clear, documented evidence — that their processes consistently produce safe, effective, and compliant products. With authorities like the FDA, EU MDR, and local

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CDSCO Updates

CDSCO Updates List of Laboratories for Performance Evaluation of IVD Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) has recently released an updated and expanded list of laboratories approved for performance evaluation of in vitro diagnostic (IVD) medical devices in India. This update is critical for medical device manufacturers, importers, and startups planning to launch IVD products in the Indian market, as performance evaluation is a key component of the regulatory

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