Innovative Quality Solutions.


Healthcare Quality in the Age of Artificial Intelligence

The changing landscape of medtech and what it means for QA/RA. Learn how you can prepare in a future with AI, along with challenges and opportunities that may come your way.


AI Revolution in Healthcare Quality

We are already using products and services based on artificial intelligence (AI) in our daily life. Facebook, Apple, Amazon and Netflix have become household names. Now AI is beginning to fundamentally reshape the rough and heavily regulated landscape of Healthcare. This presentation provides an overview of the latest applications in Healthcare and how AI is shaping FDA's vision. 


Useful Tools

Medical Device Recalls (2015 - Apr 2019)

Device Design issues are the top driver of Medical Device Recalls based as shown by analysis. Here is a quick overview of recalls since 2015.   


FDA Warning Letters (2018 - 2019 Q1)

A warning letter from the FDA is serious business! Here is a quick overview of the warning letters issued to medical device manufacturers in 2018 and 1Q of 2019 for violations observed in their Quality System. 


Robotic-Assisted Surgery Landscape

Intuitive Surgical and Stryker have dominated the market for several years but now the robotic-assisted surgery landscape is heating up with a couple of multi-billion dollar deals. Here is an overview of the industry, market leaders, recent deals and safety track record of this technology. 


Global MedTech Industry Overview

Global MedTech industry is large but highly diverse and fragmented. There are thousands of medical devices in the market. Top 10 industry leaders account for less than half of the $390 billion estimated revenues in 2018. Here is a quick overview of the industry, key players and device segments currently in the market. 


NLP in Healthcare

Medical data is expected to double every 73 days by 2020! There is an exponential increase in the quantity of data from Electronic Health Records, Medical Claims, Scientific Journals and Consumer Wearable Devices. Natural Language Processing (NLP) can be used to automate processing of this data and extraction of insights to accelerate product innovation and monitor product safety.


Machine Learning Algorithms

Recent developments in Machine Learning are now enabling robust analytical tools for data mining. Here is a summary of commonly used algorithms that can be applied to Quality data. 


Meditech Quality Journal

Complimentary monthly insights to keep you informed of vital industry news in less than 15 minutes.