October 4, 2022
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
March 10, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
If your medical device company is planning to implement quality management system software, you can’t afford to overlook the 10 most important capabilities an EQMS solution should have. Get the facts about EQMS software before you invest.
March 8, 2022
By David Jensen, Staff Writer, MasterControl
In February 2020, the FDA granted emergency use authorization (EUA) to certain medical devices needed to address the challenges imposed by the COVID-19 virus. The agency recently drafted two new guidances to make preparations for med device companies to return to normal regulatory operations.
March 1, 2022
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Medical device manufacturers need to manage risk from the beginning of product design and continue throughout the full product lifecycle - anything less jeopardizes product quality. Connected risk analysis is essential because it gives you a holistic view of risks and their potential impact. Having this level of visibility requires a digital quality management system.
February 24, 2022
By David Jensen, Staff Writer, MasterControl
Many medical device manufacturing businesses are busily exploring ways to reduce the soaring costs of health care. Medical device remanufacturer Northeast Scientific is contributing to the effort by repurposing single-use devices (SUDs) to make them fit and safe to reuse.
January 25, 2022
By Sarah Beale, Staff Writer, MasterControl
It pays to have backup plans, and the supply chain is no different. Constantly fluctuating COVID-19 protocols and transportation issues continue to plague the medical device industry, but there are steps that can be taken to deal with these problems.
January 18, 2022
By David Butcher, Staff Writer, MasterControl
While visibility, agility, and responsiveness have been priorities in managing supply chains for decades, the disruption and volatility around the COVID-19 pandemic amplified their critical role. In doing so, it brought to light the need to digitize and integrate supply chain systems to ensure all relevant data and insights can be connected for optimal resiliency.
To protect themselves in the face of supply chain volatility, medical device manufacturers should reassess their supply chain capabilities with an eye toward proactive, tech-enabled solutions.
November 4, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.
September 17, 2021
By Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc.
The vast interconnectivity of medical devices is widening the attack surface of the public health sector.
Intrusions and breaches are possible because of weaknesses in a medical device’s cybersecurity design. This post discusses the security vulnerabilities in medical devices and provides tips and resources for companies to strengthen their cybersecurity posture.
September 16, 2021
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Medical device companies can take a risk-based approach, which simplifies regulatory compliance while alleviating concerns about speed-to-market and new device clearance overhead costs to maintain compliance.
August 24, 2021
By Sarah Beale, Staff Writer, MasterControl
Gut instinct doesn’t cut it when making business decisions — especially in businesses that revolve around compliance and consumer safety. Hence the emphasis on big data and making data-driven decisions. It’s easy to say you want to use data, but to use it effectively you first need to take a step back and look at the bigger picture.
August 17, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.
August 4, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Regulatory shifts and the ever-accelerating pace of innovation are necessitating a new approach to clinical investigations of medical devices. Learn about the unique regulatory pathways that devices traverse and why recent updates to compliance standards are calling for risk-based clinical strategies.
July 19, 2021
By Lillian Erickson, Global Quality Manager, MasterControl Inc.
When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?
July 8, 2021
By David Butcher, Staff Writer, MasterControl
A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.
July 1, 2021
By Beth Pedersen, Staff Writer, MasterControl
If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?
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.
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.
April 20, 2021
By Jean Boudaud, Device Consulting Manager and Senior Consultant, Brandwood CKC, and Brandwood CKC
As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.
March 11, 2021
By José Mora, Owner, Atzari Enterprises, L.L.C.
Controlled documents tend to be weighed down with unnecessary information. When lean principles are applied to documentation practices, it becomes evident that most documents can be trimmed down to a comprehensive and useful level while maintaining compliance.
