Introduction In the ever-evolving realm of healthcare technology, Software as a Medical Device (SaMD) stands out as a...
Global Market Access Strategies for Software as a Medical Device (SaMD)
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EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe
Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses...
Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry
In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating...
Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR
As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical...
Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR
QMS (Quality Management System) and ISO 13485 A Quality Management System is defined by ISO 13485 as a set of...
OMC Medical to Showcase Global Market Access Solutions at KIMES 2024
Book time with Gayathri Ganesan: KIMES Exhibition OMC Medical Set to Attend KIMES, Invites Participants to...
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product Qualitative And Quantitative...
ARAB Health Event – Unlocking Global Markets
The ARAB Health Event is back and ready to pave the way for groundbreaking advancements in healthcare! This year, we...
Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023
Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have...
Overhauling Drug Registration: The Indonesian Food and Drug Authority’s Progressive Amendment
Drug Registration - The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and...
Comprehensive Guide to Medicinal Product Registration in Armenia: Criteria, Procedures, and Quality Standards
MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Regulatory Authority: Scientific...
Demystifying Pharmaceutical Registration in Albania: Your Ultimate Guide to Medicine, Drug, and OTC Product Approval Processes
MoH: The Ministry of Health and Social Protection. MoH website: https://shendetesia.gov.al Regulatory Authority:...