All Features
Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Paul Voss
Not long ago, most Americans could safely ignore congressional deliberations about Federal Aviation Administration (FAA) authority, leaving the details to industry experts and lobbyists. But this time, we may need to fasten our seatbelts and actually read the card in the seat pocket.
A bill under…
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…
NIST
They activate airbags. Keep aircraft correctly positioned in flight. Detect earthquakes or sudden vibrations in failing machinery. Guide military hardware. Monitor falls in elderly individuals and initiate calls for help. They rotate the display on a smartphone from vertical to horizontal, and…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Bruno Scibilia
Sponsored Content
Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Lillian Erickson
The updated version of ISO 9001, published in September 2015, generated much anxiety among companies fearing a bumpy transition to the updated and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts…
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
NIST
I
n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
John Nolan
The ultimate aim of ISO 9001:2015 is to enable businesses to satisfy their customers effectively. You could say that all the standard’s clauses help to provide your customer with a consistent and rewarding experience from your goods or services, but ISO 9001:2015 actually deals with “customer…
Gilles Hilary
Phil used to be a very senior financial executive. When asked for a number, he would typically provide with a rough ballpark answer, such as, “It’s about 5 percent.” He’d then be peppered with questions about how he had arrived at that figure.
After a while, he got tired of this questioning and…
Dan Jacob
Airbags, ignition switches, and even emissions software; although large recalls make the news at a regular pace, these are surrounded by scandal. News reports include claims of illegal or unethical activity executed by individuals or larger groups of people. Unfortunately, as new reports expose…
Mike Micklewright
When considering any effort toward performance improvement, you should always start by looking at the organization’s principles and culture, and making sure these are aligned so they not only permit positive changes to occur, but also ensure that the changes will be sustained over the long run. By…
NIST
Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or shorting…
ISO
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Stephen Mundwiller
One of the more enjoyable discussions I’ve seen on the Internet recently has to be about what to do with the quality manual. A common question is, “So what do I call this thing I put all the procedures in, now that we can’t have a quality manual?” It’s part of the panic brewing among quality…
Manufacturing Extension Partnership MEP
Whether it’s for performance management or for risk, it’s important to know who your suppliers are and have a close business relationship with them.
It’s a given you should already have a strong relationship with your key suppliers, but how often does your supplier request the following items? •…
Donald J. Wheeler
Here we look at a simple example to discover the commonalties of various data analysis techniques widely used in industry today. Careful consideration of the following may result in insights that were not part of your introductory class in statistics.
Our example uses the gate oxide thicknesses…
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
Dawn Bailey
Dorothy: Now which way do we go? Scarecrow: Pardon me, this way is a very nice way. Dorothy: Who said that? Toto barks at the scarecrow. Dorothy: Don’t be silly, Toto. Scarecrows don’t talk. Scarecrow: [points other way] It’s pleasant down that way, too. Dorothy: That’s funny. Wasn’t he pointing…