Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good...
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management...
Steve Thompson
If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are...
Kelley Jacobsen
In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders. Amid supply chain disruptions during the pandemic, hospitals scrambled to...
Jennifer Chu
Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination. And in most cases, the...
Matthew M. Lowe
Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of...
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the...
Kari Miller
Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug...
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be...
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that...
Michael King
Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country...
Melissa Phillips
The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.
But we still need to measure those contaminants and make sure our food is safe. And measuring tiny...
Matthew M. Lowe
Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done. And when you’re working in...
Kari Miller
Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance. When companies use a horizontal...
Etienne Nichols
I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1,...
Grant Ramaley
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the...
Etienne Nichols
In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct...
Liza Dzhezhora
Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions...
Del Williams
For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with...
Doug Folsom
Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable...
