While a Quality Management System (QMS) is a necessary and foundational element of any life-science...
Madison Wheeler
Using QFD for Medical Device Development
Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was...
A History of Reproductive Health
Happy National Women’s Health Week! In honor of this week bringing light to important women’s health issues, I wanted...
The Importance of Supplier Quality for MedTech
It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory...
Developing a Med Device Traceability Matrix
If you have developed a medical device, you know how important the concept of traceability is. Every facet of the...
Complying with Medical Device Labeling Requirements
A critical, yet often overlooked, part of bringing your medical device to market is ensuring it complies with all...
Siemens Healthineers Purchases Varian
2021 is shaping up to be a big year for MedTech mergers and acquisitions. Last week, Siemens Healthineers and Varian...
Understanding the J&J Vaccine Pause
Breaking news hit early this week regarding potential problems with Johnson & Johnson’s one-shot COVID vaccine,...
Mitigating Bias for Medical Devices
Human Factors Engineering is a major component of the Design Controls process for Medical Devices. Understanding how...
The FDA’s Role in Public Health
Public health is generally defined as the health of the population as a whole. The World Health Organization gives a...
Celebrating National Doctors Day!
March 30 is celebrated every year as National Doctors Day. This day is in honor of the physicians who devote their...
The Cost of Medical Device Settlements
Medical devices are made to save lives; but what happens if these devices cause more harm than good? There can be...
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