June 16, 2021
By Dr. Dirk Stynen Owner, President and Principal Consultant, Qarad
It is often crucial for safety that users have access to the correct instructions for use (IFU) when they need it. Therefore, it is logical that eIFU solutions are subject to strict requirements. Consequently, notified bodies (NB) will verify how a manufacturer has designed and implemented their eIFU solution in agreement with the requirements.
June 8, 2021
By Sarah Beale, Staff Writer, MasterControl
As companies learned during the pandemic, going digital is easier said than done. That’s why life sciences consulting firm Enterey uses a four-step process to help their clients transform their businesses. To walk us through it, we chatted with Manager Aimy Rehm about how to practically apply the steps and some potential scenarios companies may face.
June 3, 2021
By David Butcher, Staff Writer, MasterControl
New technologies are enabling innovative advances in precision medicine. They are also generating vast amounts of data – across clinical studies, laboratories, patients, products, and more. As more enormous, disparate data sets are created, organizations need to be able to track, store, and analyze the information quickly and accurately. To fulfill the promise of precision medicine, organizations must harness all that data through greater connectivity and interoperability, increased visibility, and more data-driven insights.
June 2, 2021
By Philippe Charbon, President, Apsalys
Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.
June 1, 2021
By Sarah Beale, Staff Writer, MasterControl
The quality management career has its ups and downs. We’ve already explored how to get into quality — now Quality Engineer Natalie Weber shares the good, the bad, and the hilarious parts of the job.
May 25, 2021
By Sarah Beale, Staff Writer, MasterControl
The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.
May 21, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.
May 20, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.
May 19, 2021
By Dale Thompson, Staff Writer, MasterControl
All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.
May 13, 2021
By David Jensen, Staff Writer, MasterControl
More regulated companies have transitioned to maintaining records and submitting information electronically. This involves tight data and records management and audit trails. In this article, Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc., shares valuable insight on the anatomy of an audit trail and advises companies on how to comply with this critical component of 21 CFR Part 11.
May 12, 2021
By Cameron Loper, Digital Health Leader, MPR Associates
The U.S. Food and Drug Administration (FDA) has proposed a regulatory framework around Artificial Intelligence/Machine Learning (AI/ML) for software as a medical device (SaMD). In the second part of a two-part series, past and current regulations are explored and explained.
May 11, 2021
By David Butcher, Staff Writer, MasterControl
The movement toward digitization in manufacturing isn’t new, but the events of 2020 forced many organizations to adopt digital solutions quicker than previously planned. The digital changes that companies made over the past year are likely to remain after the crisis. As manufacturers look for ways to leverage technology to improve operations, they should consider at the following four ways to apply digitization.
May 7, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.
May 6, 2021
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Early stage startups in the medical device/Medtech/in vitro diagnostic (IVD) world often struggle with when and how to implement a quality management system (QMS) into their operations.
May 5, 2021
By Cameron Loper, Digital Health Leader, MPR Associates
As Artificial Intelligence/Machine Learning (AI/ML) gain momentum, particularly in software as medical device (SaMD), a regulatory framework is being put in place by the U.S. Food and Drug Administration (FDA). In the first part of a two-part series, the benefits of AI/ML are discussed along with the numerous considerations that need to be taken into account by regulatory bodies.
May 4, 2021
By Sarah Beale, Staff Writer, MasterControl
Using the Force to make decisions in Star Wars works well. Tragically, since most of us don’t have that ability in the real world, we’d probably be better served if we listened to C-3PO more. While we’re short on protocol droids, we do have the tools to let you make decisions using advanced analytics and artificial intelligence (AI). And the odds of those paying off are considerably better than navigating an asteroid field.
May 3, 2021
By Andy Myslicki, Managing Director, Integrated Project Management Company
If you prepare for and manage compliance crises with disciplined leadership and formal processes, you can minimize disruption and damage. In fact, your processes, communication, and adaptability can get stronger from the experience.
April 29, 2021
By David Butcher, Staff Writer, MasterControl
For professionals in the business of quality, inspiration can be found in all sorts of ways, from studying other industries to browsing the patent office or even taking a different route to work. A simple but often motivating approach is to look to words of wisdom from experts in their fields. Here are five insightful quotations, from a variety of fields, that carry quite a bit of truth for quality professionals.
April 23, 2021
By David Butcher, Staff Writer, MasterControl
Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.
