Med Device Online1d
Meeting Annex 1 Regulations: A Proactive Approach To Regulatory Compliance
A major European contract manufacturing organization (CMO) producing diverse biologic drugs recognized the significant impact of the August 2023 EU GMP Annex 1 revision. This update, focused on ...
Med Device Online6d
Key QMS Considerations For Your Medical Device Startup
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...
Med Device Online11d
A Look At AI-Driven Medtech For Rare Disease Diagnosis
Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming ...
Med Device Online18d
Most Frequently Asked Questions On The Revised EU GMP Annex 1: Volume 1
Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, aiming to ...
Med Device Online19d
Achieving EU GMP Annex 1 Compliance Through An End-To-End Approach To Contamination Control
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure ...
Med Device Online27d
Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors
The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...