All Features
NIST
Arapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…
Nimax
Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices had…
Sam Schaffter
My grandfather was a carpenter, so growing up I often heard the adage, “Be sure to measure twice so you only have to cut once.” The saying is also attributed to tailors—you have to make sure your measurements are correct before you cut the fabric.
Little did I know that years later the saying…
Jennifer King
Although patient safety is paramount in healthcare settings, about 1 in 10 patients is harmed in healthcare, and more than 3 million deaths occur due to unsafe care, says the World Health Organization (WHO). The reality is hospitals and healthcare facilities face numerous challenges in managing…
Etienne Nichols
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device to a…
ISO
The digital revolution has transformed healthcare along with virtually every other industry. From telemedicine to digital health data, providers now have access to innovative solutions that have the potential to make healthcare more accessible and effective for all.
In some instances, this is done…
Knowledge at Wharton
Many countries face the reality of demographic aging: Fertility is plummeting and people are living longer. This raises critical challenges for the labor market, healthcare, and long-term care markets, as well as retirement systems and financial planning. A Wharton symposium on the implications of…
Amy Knue
Health systems across the country are unknowingly paying multiple times for the same medical equipment—once to own it, and again to rent it. The issue isn’t always an increase in clinical demand; it’s often availability and visibility to medical device inventory. The cost of these unnecessary…
Etienne Nichols
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the…
Stephanie Ojeda
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.
In contrast…
Etienne Nichols
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF): • “AI-enabled device…
Heidi Drafall
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.
The…
Jennifer Chu
Hearing aids, mouth guards, dental implants, and other highly tailored structures are often products of 3D printing. These structures are typically made via vat photopolymerization—a form of 3D printing that uses patterns of light to shape and solidify a resin, one layer at a time.
The process…
William A. Levinson
According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the facility…
Matt McFarlane
One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Report was that economic uncertainty is playing a large role in the decisions medical device companies make this year.
The report surveyed more than 500 medical device professionals across quality, regulatory, product…
ISO
Occupational health and safety (OHS) is often brushed aside as a checkbox exercise—something assigned to compliance officers or forgotten in day-to-day operations. But this mindset comes at a cost. Every year, millions of people suffer injuries, illnesses, or worse, simply because their workplace…
John O'Kelly
Warehouses are the backbone of supply chains, ensuring that goods move efficiently from suppliers to consumers. However, the physical demands of warehouse work—heavy lifting, repetitive motions, and prolonged standing—can take a toll on employees, leading to fatigue, injuries, and long-term strain…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
IDS Imaging Development Systems
The slit-lamp examination is one of the most important diagnostic techniques in ophthalmology. It enables a detailed examination of the anterior, middle, and posterior segments of the eye. Ophthalmologists can use it to recognize the smallest changes, anomalies, or damage. This procedure is used…
Matt McFarlane
The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030. New technology, new opportunities, and, as always, the promise of improving patient outcomes around the world are major drivers of growth within…
Etienne Nichols
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Stephanie Ojeda
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Ilana J. Sprongl
Back in 2023, only 15% of businesses had adopted AI-augmented software testing tools. By 2027, that number is expected to leap to 80%. The reason behind this rapid adoption is clear. The complexity of modern software and products is skyrocketing, and with it, the risks associated with quality…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…