QMS to EU IVDR

Mapping QMS to EU IVDR | Operon Strategist

Introduction With the European Union In Vitro Diagnostic Regulation (EU IVDR) now fully applicable, manufacturers must ensure that their Quality Management System (QMS) aligns with the regulation’s detailed requirements. Mapping QMS to EU IVDR is not just about ticking compliance boxes—it’s about establishing traceability, safety, and performance of IVD devices across their entire lifecycle. This […]

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CE Approval for Vacuum Blood Collection Tubes

CE Approval for Vacuum Blood Collection Tubes Under IVDR | Operon Strategist

Importance of CE Approval for Vacuum Blood Collection Tubes CE Approval for Vacuum Blood Collection Tubes is essential as these in-vitro diagnostic (IVD) medical devices are used to collect, store, and transport blood samples safely for laboratory analysis. These tubes are widely used in hospitals, diagnostic centers, and clinical laboratories for accurate testing and patient

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BIS Standards for Medical Equipment: Updated Guidelines to Strengthen Quality Compliance in India

BIS Announces Major 2025 Update to Medical Equipment Standards The Bureau of Indian Standards (BIS) has announced a comprehensive update to the BIS Standards for Medical Equipment, marking a significant milestone in India’s medical device regulatory framework. This 2025 update aims to enhance quality, safety, and performance benchmarks across the healthcare and medical device manufacturing

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SFDA Medical Device Importation and Licensing Requirements: Step-by-Step Compliance Guide

Understanding SFDA and Its Role in Medical Device Regulation The Saudi Food and Drug Authority (SFDA) regulates the importation, registration, and approval of medical devices to ensure that only safe and high-quality products are available in the Saudi Arabian market.  Through a structured and transparent review system, the SFDA ensures that all medical devices comply

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CDSCO Issues Draft Guidance on Medical Device Software to Align with Global Standards

Overview of the Draft Guidance India’s MedTech industry has largely welcomed the Central Drugs Standard Control Organisation (CDSCO) draft guidance on medical device software, issued on October 21, 2025, describing it as a progressive step toward global harmonization and digital health innovation. The 76-page draft provides comprehensive direction on the scope, classification, and quality requirements

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CE Marking of Digital Health Technologies: New Rules for Medical Device Software under the EU MDR

Introduction Digital health technologies are changing how healthcare is delivered and managed. From fitness trackers and mobile health apps to software that monitors chronic diseases like diabetes or heart conditions, these tools are now part of daily life. However, with this growth comes tighter regulation. In Europe, manufacturers of digital health technologies, wearable sensors, and

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Centre to Revise MDR 2017, Define Qualifications for Medical Device Inspectors and Analysts

The Union Health Ministry has proposed amendments to India’s Medical Devices Rules (MDR), 2017, aiming to strengthen regulatory oversight in the country’s MedTech sector. The draft Medical Devices (Amendment) Rules, 2024 introduce clear educational qualifications for medical device inspectors and government analysts through two new provisions — Rule 18A and Rule 18B. Key Provisions under

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FDA 510(k) submission for active medical devices

US FDA 510(k) Submission for Active Medical Devices: A Complete Guide

Overview: Why Active Devices Need FDA 510(k) Submission Active medical devices rely on external energy sources and therefore pose moderate risks to patients and users. Because of this, they fall under the regulatory scope of US FDA 510(k) submission. Manufacturers must demonstrate that their product is substantially equivalent to a legally marketed predicate device before

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CE Marking for Class

CE Marking for Class I, II, and III Medical Devices – Requirements and Compliance Guide

Overview of CE Marking for Medical Devices CE Marking for Class I, II, and III medical devices is a mandatory regulatory requirement for placing medical devices on the European market. It signifies that the device complies with the EU Medical Device Regulation (MDR 2017/745), ensuring safety, performance, and quality. Every manufacturer seeking to sell in

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