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.

Why the Cloud Is the Key to Easing Your Validation Burden

If your organization spends several weeks or months performing software validation, you’re not alone. Most regulated companies do. But, Erin Wright, MasterControl’s validation product manager, said validation doesn’t have to be as burdensome anymore. The powerful cloud technology, combined with a risk-based approach, is the key to a faster and better validation process.

"Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 1"

A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

How to Gain Entry to Latin America’s Medtech Market

Don’t get bit by piranhas and crocodiles when entering Latin America’s lucrative $31 billion medical device manufacturing industry. Learn from a pro the tips, strategies and trends you’ll need to be successful in the golden medtech market in North and South America.

Using an Integrated QMS to Qualify Your Suppliers

Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

Regulatory Barriers to Innovation for Startups

France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

Best Practices for Supplier Evaluation and Rationalization

Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

Using the Newly-Approved Dietary Fibers in Supplements

Many consumers don't get enough fiber, leading to health problems that are especially prevalent as people get older. Fiber supplements can help fill the gap, and now the FDA has expanded its definition of dietary fiber to include eight more sources.

The #1 Gap in Manufacturing Software Today

It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. Why is it that the truly paperless factory floor remains so elusive?

Regulatory Manager Tip: Making Your Voice Heard at the FDA

As a life science manufacturer, how can I minimize risk and hiccups before seeking U.S. Food and Drug Administration approval for my product? Learn how to make your voice heard at the FDA in this month’s Regulatory Manager Tip.