资讯

Med Device Online1 天
Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials
Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...
Med Device Online1 天
Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, ...
Med Device Online3 天
Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications
Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports ...
Med Device Online8 年
Non-Porous Package Test System - Med Device Online
Carleton Technologies, Inc. announces a replacement for the Test-A-Pack Model F099-1080-13 Integrity Tester. The new Test-A-Pack Model F100-2700-2 Non-Porous Package Test System provides a simple, ...
Med Device Online18 天
What To Expect When You Move Into Production For The First Time
In medical device development, things don’t go quite as you planned the first time around. This article shares what to really ...
Med Device Online3 天
Medical Device Manufacturer Implements A Next-Gen MES At A Third Of The Cost
A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and ...
Med Device Online3 年
FDA Releases Guidance On Cybersecurity In Medical Devices
<p>The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA&#39;s latest efforts to enhance medical device cybersecurity ...
Med Device Online4 年
An Introduction to Polymeric Materials for Medical Devices
This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...
Med Device Online1 年
Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests
The proposed FDA regulation for laboratory developed tests (LDTs), as outlined in FDA-2023-N-2177-0001, marks a significant step toward the FDA trying to standardize oversight for these diagnostic ...
Med Device Online3月
A Look At AI-Driven Medtech For Rare Disease Diagnosis
Rare diseases affect over 300 million people worldwide, with more than 7,000 identified conditions. 1 Despite this prevalence, patients often face a diagnostic odyssey lasting 5 to 7 years, leading to ...
Med Device Online3 年
3 Successful Strategies For Patenting Diagnostic Technologies
Over the past decade, the Supreme Court has made the formerly simple analysis of patent eligibility into a complex mixture of hard-to-reconcile precedents. The Supreme Court’s Mayo and Myriad opinions ...
Med Device Online4 年
Polymeric Materials And Coronary Angioplasty Devices
Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...