All Features
Chris Rush
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.
Real-world data (RWD), which typically come from routine healthcare delivery or…
Stephanie Ojeda
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.
With the rise of digital…
Zach Winn
Most doctors go into medicine because they want to help patients. But today’s healthcare system requires that they spend hours each day on other work—searching through electronic health records (EHRs), documenting, coding and billing, gaining prior authorization, and evaluating services—that often…
ISO
Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.
Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient data, including…
Saurabh Joshi Shripad
Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry, regulators, and patient rights groups, recognized…
Laura Velásquez Herrera
With its roots in compassion and humanity, the healthcare sector might seem an unlikely place for artificial intelligence (AI) to play a big role. Yet as we look deeper into the complex processes that build our medical systems, we uncover a multitude of ways that AI could revolutionize patient care…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
Robyn Coward, Brian Brooks
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle.”…
Del Williams
In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment. However, when not designed or installed properly, bulk discharge systems can become a production bottleneck.
Complicating the issue…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
ISO
When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations. However, when they see a patient online, they may lack the necessary equipment to conduct the visit properly. One reason for this is that virtual care…
Lawrence Goodman
Here are just a few potential advantages of 3D drug printing—a new system for manufacturing drugs and treatments onsite at pharmacies, healthcare facilities, and other remote locations: chocolate-flavored pills for children who hate taking medicine; several drugs combined into one daily pill for…
Etienne Nichols
If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of records…
Stephanie Ojeda
Look through even a few FDA warning letters and you’re likely to find violations related to change management.
For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification. Another noted a lack of…
Veronica Muzquiz Edwards
Health connects each one of us to one another. No matter where we are in the world, who we are, or what we do, the state of our health is a key determinant in our quality of life. Simply put, it’s our most valuable asset.
Individual health crises can be disastrously grim, and if not addressed…
Etienne Nichols
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class…
Stephanie Ojeda
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management software. The…
Aman Pandey
In the dynamic landscape of the life sciences industry, ensuring compliance with good manufacturing practices (GMP) is imperative to guarantee the safety, efficacy, and quality of pharmaceutical products.
One critical aspect of GMP is the analytical product quality review (APQR), an essential…
Dawn Bailey
The Center for Organ Recovery & Education (CORE), a 2019 Baldrige Award recipient, is a nonprofit organ procurement organization (OPO) in Pittsburgh with a federally designated service area encompassing a population of 5.5 million in western Pennsylvania, West Virginia, and one county in New…
Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand, financial uncertainty, and fast-changing cybersecurity risks.
Because clinical assets account for an average of…
Alonso Diaz, Maria DiBari
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
Maggie Overfelt
Michele Gelfand finds inspiration for new projects all around her: taking in the banter in a boardroom, speaking with taxi drivers when traveling, observing the interactions between physicians and nurses during an unexpected trip to the doctor. The idea for one of her most recent papers was sparked…
NIST
Stain-resistant clothing, fast-food wrappers, and extreme weather gear such as certain jackets and pants—these products get many of their desirable features from a class of manufactured chemicals called per- and polyfluoroalkyl substances (PFAS). But there’s a major downside: Researchers have found…
