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

Leveraging the Value of Quality in Your Business Through ISO

Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.

"Ugly Babies, Silent Enemies and Other Short Stories from a Continuous Improvement Conference"

Continuous improvement professionals, managers, and executives from the U.S. and Canada presented at the recent Canadian Lean Conference in June 2018, which drew about 1,000 business leaders to Winnipeg. Presenters shared lessons and results from lean transformation efforts as well as some personal journeys. Here’s a digest of some of the stories I heard.

Keeping Up With Regulatory Changes for Medical Devices

Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.

Pregnancy and Medical Device Submission Management: Can the Pain Be Reduced?

At first glance, the processes of human pregnancy and medical device submission management are as “non-workable” as peanut butter and cinnamon or popcorn and ketchup. However, it’s surprising how many pains these two forms of labor have in common.

7 Ways That Medical Device Design Control Helps the Design Engineer

The design and development of a medical device can be fraught with surprises and challenges for the design engineer. Learn how to avoid these hiccups by implementing solid design controls that can help the process run smoother, and better yet, see the device ready on-time and on-budget.

Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?

One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.