Operon Strategist

Quality of Used Medical Devices

Concerns Raised by Parliamentary Panel on Quality of Used Medical Devices

Parliamentary Update on Quality of Used Medical Devices The Parliamentary Standing Committee on Chemicals and Fertilisers has voiced apprehensions about the inadequate regulatory framework concerning the assessment of quality, safety, and efficacy of second-hand or used medical devices. This deficiency, the panel asserts, compromises the standard of healthcare services in the nation. In response, the […]

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European NB opinion for drug-device combination products

Navigating the European NB Opinion Process for Drug Device Combination Products

An Overview: In the dynamic realm of healthcare innovation, the convergence of pharmaceuticals and medical devices has led to the development of groundbreaking combination products. However, ensuring the safety and efficacy of these products requires navigating a complex regulatory landscape. For those seeking to introduce drug-device combination products to the European market, obtaining a Notified

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Haryana's Medical Device Manufacturing Policy 2024

Haryana’s Medical Device Manufacturing Policy 2024 Targets ₹3000 Crore Investment

Haryana’s Bold Vision In a groundbreaking move, the Government of Haryana unveils its transformative vision to establish the state as a global leader in medical device manufacturing. Mission for Progress The Draft Haryana Medical Devices Manufacturing Policy, 2024, sets forth a comprehensive mission aimed at creating a thriving ecosystem for the development and production of

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Risk analysis of drug-device combination products

Navigating the Complexity: Risk Analysis of Drug-Device Combination Products

Introduction: Risk Analysis of Drug-Device Combination Products In the realm of modern healthcare, the convergence of pharmaceuticals and medical devices has led to the development of innovative treatment modalities known as drug-device combination products. These products offer unique therapeutic solutions by combining the benefits of pharmaceuticals with the precision and functionality of medical devices. However,

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Ujjain medical device park

5 Companies Propose to Invest ₹176 Crore at Ujjain’s Medical Devices Park

Update on Ujjain Medical Device Park Boosting Healthcare Infrastructure Five companies have committed to investing a combined total of Rs 176 crore in the Medical Devices Park situated in Ujjain, seeking around 26 acres of land from the Madhya Pradesh Industrial Development Corporation (MPIDC). These proposals, aimed at bolstering employment opportunities, promise to create approximately

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HIPAA compliance and cybersecurity

Ensuring HIPAA Compliance and Cybersecurity for Software as Medical Devices

Overview of HIPAA Compliance and Cybersecurity In the medical device sector, discussions on Software as Medical Devices (SaMD) and cybersecurity are gaining momentum as the FDA introduces regulatory guidelines for digital platforms. Manufacturers are exploring novel ways to utilize software for gathering patient data, emphasizing the importance of safeguarding patient data privacy and mitigating potential

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EU MDR technical documentation

What Notified Bodies Look for in EU MDR Technical Documentation

Introduction- If you’ve been navigating the complex realm of medical device regulatory affairs for over five years, you’re undoubtedly familiar with the ever-tightening requirements surrounding technical documentation for European CE Marking. The implementation of the Medical Device Regulation (MDR 2017/745) has significantly altered the landscape, placing greater demands on manufacturers to achieve compliance. This shift

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medical device market

Navigating the Medical Device Market Entry Gameplan: The EU and The US Analysis

Overview: How to Launch Medical Devices to the Market Bringing a medical device to the market is a rigorous process that involves navigating complex regulatory frameworks. In particular, launching medical devices in the European Union (EU) and the United States (US) presents unique challenges and opportunities for manufacturers. Understanding the differences between these two major

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Audit and Inspection of Medical Device

Parliamentary Panel Asks the Government to Notify More Bodies for Audit and Inspection of Medical Device Units

Introduction: A recent report by a Parliamentary Panel has highlighted concerns regarding the insufficient number of notified bodies available for auditing and inspecting medical device manufacturing units in the country. The panel emphasized the necessity of prompt action in notifying more bodies and ensuring thorough inspections to maintain quality standards in the medical devices industry.

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