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February 16, 2024
An executive summary of the regulatory requirements for in-vitro diagnostic medical devices, wellness and fitness products, and aesthetic products in North America, EU, and Asia including India:

In-vitro Diagnostic Medical Devices

North America: The FDA regulates in-vitro diagnostic...

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February 09, 2024
Post-Covid Developments and Essential Skills for Employees in the Medical Device Industry (2023-2024)

The medical device industry has been significantly impacted by the Covid-19 pandemic, leading to ...

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February 02, 2024
Challenges in the Medical Device Industry in 2024: A Global Perspective

The medical device industry is a dynamic and rapidly evolving sector, with advancements in techno...

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January 26, 2024
A Picture is Worth a Thousand Words - Food For Thought Mehrtash Soltani, PhD

After watching this video, I came to understand the importance of having experienced individuals ...

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January 25, 2024
Voice - Regulatory Experts On ISO 10993-1 by Helin Raagel and Audrey Turley

Regulatory experts at Nelson Labs break down the latest FDA guidance on biological evaluation of ...

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January 24, 2024
Regulatory Affairs 1o1 by Ethan Drower

Let's talk about the often-overlooked but oh-so-important aspect of regulatory affairs:

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January 22, 2024
Opinion - An Integrated System for Cybersecurity, Design Controls and Risk Management throughout the PLC by Fubin Wu

A fully integrated system for cybersecurity, design controls and risk management throughout the p...

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January 22, 2024
Summary - A Rundown of MedTech Expert Panel Discussions, including MDR Article 61 (10) by Sean Smith

In case you missed it. 👇👇
A quick rundown of expert panel discussions, including MDR Article ...

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January 22, 2024
Remark - FDA's Adoption of ISO 13485 by Gregory Jacobson

Pictured is Tim Gooch presenting on the FDA's adoption of ISO 13485 at MD&M Minneapolis.

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