Operon Strategist – Page 16 – Operon Strategist

How to Sell Medical Devices in European Countries: A Step-by-Step Guidance

Selling Medical Devices in Europe: An overview Europe presents a valuable yet highly regulated market for medical device manufacturers. With the enforcement of the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR), companies must navigate detailed compliance procedures to ensure their products meet strict regulatory standards. Whether you’re introducing a […]

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Comprehensive Guide to Setting Up an IVD Manufacturing Plant

Overview of IVD Manufacturing Plant In Vitro Diagnostics (IVD) products are indispensable tools in modern healthcare, allowing for the diagnosis and monitoring of diseases by analyzing samples like blood, urine, and tissues outside the human body. Setting up an IVD manufacturing plant requires careful planning, regulatory compliance, and strategic investment. This blog outlines key details

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PLI Investments to Hit ₹2 Lakh Crore: MedTech Gains from Tech Transfers

An Overview: Marking a decade of the “Make in India” initiative, the Production Linked Incentive (PLI) Scheme is set to drive major investments and technological advancements across key industries, including the medtech sector. PLI Scheme Investment to Reach ₹2 Lakh Crore Minister of Commerce and Industry, Piyush Goyal, announced that PLI Scheme investments are expected

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Best Practices for Internal Auditing of ISO 13485:2016 QMS

Internal Auditing of ISO 13485:2016 QMS: An Overview As a medical device regulatory consulting firm, we’ve seen firsthand the value of thorough, well-executed internal audits of a Quality Management System (QMS). Conducting these audits regularly not only ensures compliance with ISO 13485:2016 but also identifies and resolves potential nonconformities before external audits. This is especially

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8 Key Steps to Establishing a Risk-Based CAPA Process

Risk-Based CAPA Process Corrective and Preventive Actions (CAPA) are crucial components of quality management systems, particularly in medical devices, pharmaceuticals, and manufacturing industries. A risk-based CAPA process helps organizations prioritize and address issues effectively, ensuring product quality and compliance with regulatory standards. Companies can create a risk-based CAPA process and comply with the latest revision

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Ministry of Textiles introduces Quality Control Order for Medical Textiles

Quality Control Order for Medical Textiles In a major step toward improving public health and safety, the Indian Ministry of Textiles has announced the enforcement of the Medical Textiles (Quality Control) Order, 2023, which will take effect on October 1, 2024. This order establishes strict quality standards for essential medical textile products, including sanitary napkins,

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Government to Strengthen Quality Monitoring of Imported Medical Devices with Risk-Based Approach

Quality Monitoring of Imported Medical Devices The government is set to enhance the quality control of imported medical devices by adopting a risk-based approach. This new initiative will involve random sampling for quality testing, while critical diagnostic kits will undergo comprehensive testing of the entire shipment. A guidance document has been issued to assist port

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Custom Clearance of Your Medical Devices

Custom Clearance of Your Medical Devices: An Overview The medical device industry faces unique challenges when it comes to custom clearance due to stringent regulations and administrative complexities. As regulatory bodies like MDA (Medical Device Authority) and customs authorities introduce new layers of requirements, companies must navigate a series of compliance, logistical, and operational hurdles.

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Indigenous Medical Device Manufacturing: A Global Push Towards Self-Sufficiency

Indigenous Medical Device Manufacturing In recent years, there has been a significant shift towards establishing indigenous medical device manufacturing setups in various countries around the world. Governments are taking bold steps to reduce reliance on imports by promoting local manufacturing, creating self-sufficiency, and boosting the domestic medical device industry. This movement is reshaping the healthcare

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CDSCO Issues Draft Guidance on Risk-Based Approach for Monitoring Quality at Ports of Import

CDSCO Issues Draft Guidance on Risk-Based Approach for Monitoring Quality at Ports of Import: An Overview The Central Drugs Standard Control Organization (CDSCO) has released a draft “Guidance Document on Risk-Based Approach for Monitoring Quality at the Ports of Import” for feedback. The document outlines a comprehensive strategy to regulate the import and export of

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