Operon Strategist – Page 9 – Operon Strategist

PLI Scheme Boosts Domestic Manufacturing, Jobs, and Exports

PLI Scheme: The Road Ahead The PLI scheme is a cornerstone of India’s strategy to attract investments in key sectors, enhance manufacturing efficiency, and achieve economies of scale. By fostering global competitiveness, the scheme is expected to significantly boost production, employment, and economic growth in the coming years. With a focus on cutting-edge technology and […]

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Australia update for post market surveillance

Australia Introduces New Procedures for Recalls (PRAC) in Post-Market Surveillance Medical Devices

Australia’s New Procedures for Recalls (PRAC) in Post-Market Surveillance Medical Devices On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) rolled out new guidelines called the ‘Procedures for Recalls, Product Alerts, and Product Corrections’ (PRAC), bringing important updates to how medical devices and other therapeutic products are handled after they hit the market. This

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eQMS Medical Device Migration: Essential Steps to Avoid Chaos

Transitioning to a new eQMS Medical Device is a strategic move for medical device manufacturers looking to enhance efficiency, ensure regulatory compliance, and streamline quality processes. However, a poorly executed migration can result in compliance failures, data integrity issues, and operational disruptions. At Operon Strategist, we specialize in eQMS Medical Device implementation and validation, ensuring

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Understanding the Impact of MDCG 2019-6 Rev. 5 on EU Medical Device Manufacturers

Introduction The regulatory landscape for medical devices in the EU continues to evolve under MDR 2017/745, posing new challenges for manufacturers. The recent update to MDCG 2019-6 (Rev. 5) aims to provide a more structured framework for interactions between manufacturers and Notified Bodies (NBs). However, leading industry organizations—MedTech Europe, AESGP, Medtech & Pharma Platform Association,

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Effective Risk Assessment Medical Device Management: Handling Reasonably Foreseeable Misuse

Managing Reasonably Foreseeable Misuse in Risk Assessment Medical Device When it comes to risk assessment medical devices, a lot of focus is placed on use errors and usability engineering principles (like those in IEC 62366-1). However, ISO 14971:2019 defines reasonably foreseeable misuse as more than just use errors. It’s about anticipating how a device could

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Indian Medical Device Industry Faces Challenges Amid US Reciprocal Tariffs

About US Reciprocal Tariffs on Indian Medical Devices The Indian medical device sector is poised to face significant disruptions due to the reciprocal tariffs imposed by the United States under Donald Trump’s administration. These measures are intended to counterbalance import duties levied by key trading partners, including India. As a result, the increased cost of

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Breaking Down ISO 13485: What Every MedTech Professional Should Know?

ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the medical device industry. If you’re a MedTech professional—whether a manufacturer, supplier, or service provider—understanding and implementing ISO 13485 is crucial for ensuring product safety, meeting regulatory requirements, and expanding into global markets. In this blog, we break down ISO 13485 in

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Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation?

Clinical Study vs. Clinical Evaluation: An Overview If you’re in the medical device industry, you’ve probably come across the terms Clinical Study and Clinical Evaluation more than once. While they might seem similar, they serve different purposes and are used in different situations. Understanding these differences is crucial, especially when navigating regulatory requirements for market

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How Regulatory Compliance Automation Simplifies Medical Device Processes

Regulatory Compliance Automation: A Game-Changer in the Medical Device Industry In today’s fast-paced medical device sector, regulatory compliance automation has emerged as a vital solution for navigating the complex world of regulations. By leveraging advanced technology, automation helps streamline essential regulatory processes, reducing the burden of manual tasks and ensuring smoother operations. From document management

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Challenges and Solutions in Obtaining BIS Certification for Medical Devices

Identifying the Challenges in BIS Certification for Medical Devices Getting BIS certification for medical devices can feel like a long and complex journey, but it’s a crucial step if you want to enter the Indian market. This certification ensures your product meets safety, quality, and performance standards. However, manufacturers often face hurdles along the way.

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