Santa Embraces Manufacturing Excellence

When you’ve got a hard deadline, efficiency is everything and no one knows this better than Santa. While he has the entire year to prepare for December 25th, he’s also preparing up until the last second to ensure he’s got everything ready for the big day. To pull this off, he needs a reliable digital production records solution.

From Smart to Brilliant and Beyond: 3 Ways AI Is Changing Manufacturing

Artificial intelligence (AI) offers unprecedented opportunities for productivity and economic growth in manufacturing and other key industries. Manufacturers are already leveraging AI on the factory floor in highly innovative ways and seeing measurable results.

The Importance of Knowing What You Don’t Know About Drug Development

New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.

"The Medical Device Single Audit Program: Accessing International Markets, Part 1"

Regulatory change is a near constant in the medical device industry. One of the newest systems to the international medtech scene is the Medical Device Single Audit Program (MDSAP). Find out what is required to implement MDSAP in this first of a three-part series

How Supervillains Could Benefit From a Manufacturing Operations Solution

In the epic good vs. evil paradigm in superhero movies, supervillains could actually improve their odds if they used the right technology. This article looks at three noted supervillains and discusses how their nefarious agendas might have been more successful had they used a digital manufacturing operations solution.

PwC Report Analyzes Health Care Policy Issues

PwC’s Health Research Institute recently issued a report on the U.S. midterm election that analyzes policy issues that may well impact the American health care industry for years to come, particularly those in the pharmaceutical and life science industries. Learn what this means for manufacturers.

Advancing the Regulatory Profession in Utah

Based on recent economic study and the establishment of the Silicon Slopes technology corridor, Utah has one of the fastest-growing life sciences communities in the U.S. Learn about the Regulatory Affairs Professionals Society’s (RAPS) new Utah Chapter and what the organization is doing to attract more regulatory affairs experts to life sciences careers.

De Novo Becoming Faster and Easier Pathway to Market

There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.

What's Hiding in Your Labeling Artwork?

Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

Advancing the Case for Quality in Medical Device Manufacturing

We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.

BraveHeart Team Emphasizes Quality-First Approach

One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.

FMEA Without Tears: A Prescription to Reduce Pain and Confusion

Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.

Airplane Preflight Check Exemplifies Quality in Med Device Design

Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.

Getting Paid: A Shifting Medical Device Reimbursement Landscape in Australia

Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.

Med Device Company Takes Flight With Life-Changing Innovation

Startup ventures are the embodiment of innovation – often hitting the ground running with little more than an idea and a vision. Part one of this three-part series introduces startup medical device company, BraveHeart Wearable Life Sensors, and how it is uniquely inspired by aviation.

Expert Tips on Enhancing CAPA Through Innovation

This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.

New Digital Pathways Boost Success Rate of Med Device Introductions

Launching a med device always has a sense of urgency. However, failing to gain market approval or facing a recall can be costly. You avoid these scenarios with new digital pathways that facilitate faster and more efficient regulatory information management (RIM) and product life cycle development.

"The Evolution of Medical Device Clinical Trials, Part 2"

Regulatory shifts and global advancements are reshaping the way medical device companies approach their clinical trials. Learn about the present state of medical device regulatory compliance and envision the future of the clinical landscape for devices.

The Globalization of Clinical Data in Medtech

Regulatory agencies are increasingly demanding prospective clinical data as part of the clinical evidence for medical device market access. That is increasing the costs borne by manufacturers. The silver lining: the acceptance of foreign data by those agencies, including China, is also on the rise.

QUALITÉ 4.0 : DIX ÉTAPES POUR RÉUSSIR LA MISE EN PLACE D’UN EQMS