Understanding the Regulatory Aspects of Blood Bag Manufacturing: Insights from Operon Strategist Blood bags play a crucial role in the...
Meeting the Quality Management System Requirements of a Device: A Guide to IVDR Introduction: The In Vitro Diagnostic Regulation (IVDR)...
Understanding the Comprehensive Methodology for Ensuring Quality and Compliance in Biopharmaceutical Development Biopharmaceutical development is a complex and highly regulated...
A Guide to Selecting Medical Device Software for Development under QMS In today’s technologically advanced world, medical device software plays...
Step-by-Step Guidance: Essential Tips for Medical Device Startups (Dos and Don’ts) by Operon Strategist Starting a medical device startup can...
Starting a medical device startup can be an exciting and rewarding venture. However, it is crucial to navigate the complex...
The Synergy Between Product Lifecycle Management (PLM) and Quality Management System (QMS) Solutions in MedTech In the fast-paced and highly...
Introduction to SAHPRA Guidelines on Establishment Licensing The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating the...
Greenlight Guru, a leading provider of quality management software (QMS) for the medical device industry, has been recognized as the...
Navigating India’s Medical Device Licensing Landscape: A Comprehensive Guide to CDSCO Form MD-3, MD-5, MD-7, and MD-9 by Operon Strategist...
If you are a manufacturer of In Vitro Diagnostic (IVD) devices and looking to enter the European market, one of...
Decentralized clinical trials (DCTs) have gained significant attention in recent years due to their potential to improve patient access, reduce...
A Comprehensive Guide for Japanese Medical Device Exporters: Obtaining a CDSCO Import License with Operon Strategist Introduction: Exporting medical devices...
Understanding the Importance of a Properly-Scaled Quality Management System in Study Startup In the field of clinical research, study startup...
Essential Tips for Successful Medical Device Manufacturing: A Comprehensive Guide Medical device manufacturing is a complex and highly regulated industry...
