Med Device Online2d
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 Online3d
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 Online10d
Most Frequently Asked Questions On The Revised EU GMP Annex 1: Volume 2
Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing ...
Med Device Online11d
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 Online19d
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 ...
Med Device Online22d
Mastering FDA Inspections: The Prep Work For Regulatory Success
In the medical device industry, the stakes of an FDA inspection are high. Non-compliance can lead to delayed market access, product recalls, or regulatory actions that can jeopardize a company’s ...
Med Device Online28d
Telehealth In 2025 And Beyond: The Future Is Bright
The rapid evolution of telehealth is transforming how patients access — and physicians provide — care, a shift accelerated by policy changes adopted during the COVID-19 pandemic. The announcement in ...