Innovative Quality Solutions.



The Art and Science of Risk Management

Varying perceptions of risk yield inconsistent analytics and results. Creating standard risk management processes can help to ensure consistent risk decisions.


Cybersecurity - Next Frontier of Risk Management

Our presentation at the ASQ Jacksonville Section Meeting explores the risks of cyber attacks and offers 3 recommendations for medical device risk management.


Lifecycle Risk Management of Combination Products

Our 2nd Annual CPLM Summit presentation explores disruptive changes ahead in MedTech and why risk management is more important now than ever before.


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


Timeline of FDA Actions Related to Medical Device Cybersecurity

Cybersecurity is fast emerging as the next challenge for risk management of medical devices. Here is a quick summary of FDA guidance on pre-market and post-market cybersecurity management.


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. 

Meditech Quality Journal

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