FDA Features

Jon Speer's picture
Jon Speer
Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works...
Jon Speer's picture
Jon Speer
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens...
Rupa Mahanti's picture
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the...
Sheng Lin-Gibson's picture
Sheng Lin-Gibson
Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases...
Randall Goodden's picture
Randall Goodden
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
What a year. No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX...
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Quality Digest
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk...
The QA Pharm's picture
The QA Pharm
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit! This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it...
Heather Thompson's picture
Heather Thompson
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a...
Dileep Thatte's picture
Dileep Thatte
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne...
Boris Liedtke's picture
Boris Liedtke
In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion...
Jon Speer's picture
Jon Speer
When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should...
Steven Brand's picture
Steven Brand
The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers. And they’re not just demanding it; they’re “voting with their dollars...
Peter Rose's picture
Peter Rose
On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU...
Stephen McCarthy's picture
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality...
Jennifer Lopez's picture
Jennifer Lopez
Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the...
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Stephanie McArdle
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible. The ASR program originally launched in...
Grant Ramaley's picture
Grant Ramaley
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1...
Jon Speer's picture
Jon Speer
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized...
Matthew M. Lowe's picture
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace...