Operon Strategist – Page 20 – Operon Strategist

Understanding ISO 13485 Resource Management: Key to Quality Medical Device Manufacturing

ISO 13485 Resource Management – Overview In the medical device industry, maintaining high standards of quality and safety is paramount. One of the critical components that ensure these standards is effective resource management, as outlined in ISO 13485. This international standard specifies the requirements for a comprehensive Quality Management System (QMS) specifically tailored to the […]

Understanding ISO 13485 Resource Management: Key to Quality Medical Device Manufacturing Read More »

Regulation (EU) 2024/1860: Extension of IVDR Transitional Period and New Provisions

Extension of IVDR Transitional Period The Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), has been published in the Official Journal of the European Union (OJEU). This legislation aims to ensure the continuity of supply for in vitro diagnostic devices on the European market. It also revises provisions related to

Regulation (EU) 2024/1860: Extension of IVDR Transitional Period and New Provisions Read More »

WHO Launches MeDevIS: Global Platform for Medical Device Information

WHO Launches MeDevIS Platform The World Health Organization (WHO) has introduced MeDevIS (Medical Devices Information System), a new online platform aimed at improving global access to medical technologies and devices. MeDevIS is heralded as the world’s first open-access clearing house for comprehensive information on medical devices, supporting informed decision-making by governments, regulators, and users regarding

WHO Launches MeDevIS: Global Platform for Medical Device Information Read More »

Tips to Export Medical Devices Without CE Marking

Export Medical Devices Without CE Marking: An Overview Exporting medical devices without CE marking can be a strategic move for manufacturers targeting markets outside of Europe. While CE marking is typically required for medical devices sold within the European Economic Area (EEA), many countries outside this region have their own regulatory requirements. You can export

Tips to Export Medical Devices Without CE Marking Read More »

The Rise of Automation in Medical Device Manufacturing

Automation in Medical Device Manufacturing – Overview The medical device industry is experiencing a transformative shift with the rise of automation. This evolution is enhancing precision, efficiency, and consistency in the production of medical devices. As automation continues to redefine the landscape, it brings forth numerous benefits and challenges that manufacturers must navigate. This blog

The Rise of Automation in Medical Device Manufacturing Read More »

8 Important Steps to Achieving Medical Device Approval

An Overview: Introducing a new and innovative medical device to the market has the potential to significantly enhance the health and well-being of millions. However, before your device can make its mark, it must successfully navigate the intricate regulatory approval processes in the European Union (EU), the U.S., and other major jurisdictions worldwide. For first-time

8 Important Steps to Achieving Medical Device Approval Read More »

Breathing Apparatus Manufacturing: From Design to Approval with Operon Strategist

Comprehensive Guide to Breathing Apparatus Manufacturing Breathing apparatus manufacturing is a complex yet essential process that ensures respiratory protection across various industries, including healthcare, emergency response, and industrial safety. These life-saving devices must meet strict quality and regulatory standards to guarantee safety and performance. At Operon Strategist, we specialize in guiding manufacturers through every stage

Breathing Apparatus Manufacturing: From Design to Approval with Operon Strategist Read More »

Diagnostic Kit Manufacturing and Regulatory Compliance

Introduction to Diagnostic Kit Manufactruing: The diagnostic kit industry is rapidly expanding, fueled by breakthroughs in biotechnology and the global demand for accessible, accurate healthcare solutions. Diagnostic kits such as rapid diagnostic tests (RDTs), polymerase chain reaction (PCR) kits, and enzyme-linked immunosorbent assays (ELISAs) are essential tools for early disease detection, monitoring, and public health

Diagnostic Kit Manufacturing and Regulatory Compliance Read More »

An In-Depth Guide to Ophthalmic Imaging Devices: Manufacturing, Compliance, and Regulatory Insights

Fundamentals of Ophthalmic Imaging Devices Ophthalmic imaging devices are vital tools in modern eye care, offering the ability to diagnose and monitor a range of eye conditions with accuracy. These devices capture high-resolution images of the eye, helping healthcare professionals detect issues like glaucoma, diabetic retinopathy, and macular degeneration. Given their importance, the manufacturing of

An In-Depth Guide to Ophthalmic Imaging Devices: Manufacturing, Compliance, and Regulatory Insights Read More »

DGFT Empowers EPC to Issue Export Certificates for Medical Devices

Boost for Medical Device Exporters as New Directive Expands Certification Authority In a significant development for India’s medical device industry, the Directorate General of Foreign Trade (DGFT) has authorized the Export Promotion Council for Medical Devices to issue Registration-Cum-Membership Certificates (RCMC), facilitating smoother exports and streamlined customs processes. Key Points: Medical device manufacturers now have

DGFT Empowers EPC to Issue Export Certificates for Medical Devices Read More »