Guest Columns
-
Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines
7/8/2024
This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them.
-
Is Mexico A Prime Location For Medical Device Clinical Trials?
6/27/2024
Mexico, one of Latin America's largest economies and most populous countries, is emerging as a prime destination for medical device clinical trials and other advanced medical technologies.
-
System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
6/26/2024
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
-
8 Best Practices For Securing Investment In Diagnostics
6/25/2024
To attract and secure investments in today's landscape, medtech and diagnostic companies should consider adopting these 8 strategies to highlight value and potential for growth.
-
The Growing U.S. Market For Endoscopic Gastrointestinal Devices
6/21/2024
Ongoing technological advancements have made gastrointestinal endoscopes smaller and more efficient. This article looks at the growing U.S. market for such devices.
-
Medical Device Assembling And Packaging: Should You Outsource?
6/18/2024
Medical device assembly and packaging are often afterthoughts, but they are critical decisions. Consider these crucial factors to make the right decision for your device and your company.
-
Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm
6/6/2024
The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.
-
Balancing Sustainability With Patient Safety In Medical Device Design
6/3/2024
There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.
-
5 Innovative Ways To Bring DHTs To Market Successfully
5/30/2024
Real-world examples demonstrate how digital health technology (DHT) developers can navigate the regulatory pathway while optimizing opportunities for downstream patient access.
-
Clinical Investigation Plans: The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV, ISO 14155
5/22/2024
The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How does it complement existing guidance and regulation?