• The Globalization of Clinical Data in Medtech

    18 September, 2018 by Danielle Giroud, Founder and CEO, MD-Clinicals (Switzerland)

    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.

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  • How to Approach Design Control From Both FDA and ISO Viewpoints

    13 September, 2018 by Mike Rigert, Staff Writer, MasterControl

    Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.

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  • Leveraging the Value of Quality in Your Business Through ISO

    11 September, 2018 by Christine Park, Founder and Owner, Christine Park and Associates

    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.

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

    6 September, 2018 by Chet Marchwinski, Communications Director, Lean Enterprise Institute

    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.

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  • Keeping Up With Regulatory Changes for Medical Devices

    4 September, 2018 by Michelle Lott, Principal and Founder, Lean RAQA

    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.

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  • Top 5 Nutraceutical Trends in 2018 – Functional Foods

    30 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    The dietary supplement and functional foods markets overlap to a certain extent. Rather than trying to resist this, nutraceutical companies can get the best of both worlds by expanding their offerings to include functional snacks and beverages.

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

    29 August, 2018 by Marci Crane, Staff Writer, MasterControl

    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.

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  • 7 Ways That Medical Device Design Control Helps the Design Engineer

    28 August, 2018 by Edwin Waldbusser, Medical Device Regulatory Consultant, Medical Device SOP Advisors

    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.

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  • Avoiding the Top 5 Violations of 21 CFR Part 111

    23 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    All dietary supplement companies must comply with the CGMPs outlined in 21 CFR Part 111. However, doing this and recording it is easier said than done. The top 5 violations recorded by the FDA show which areas need the most improvement and how automated systems can help

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

    21 August, 2018 by Mike Rigert, Staff Writer, MasterControl

    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.

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  • Why the Cloud Is the Key to Easing Your Validation Burden

    16 August, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    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.

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  • Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2

    15 August, 2018 by Carla Frances Reed, President, New Creed

    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.

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

    14 August, 2018 by Carla Frances Reed, President, New Creed

    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.

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

    9 August, 2018 by David Jensen, Staff Writer, MasterControl

    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.

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  • How to Gain Entry to Latin America’s Medtech Market

    7 August, 2018 by Julio G. Martinez-Clark, CEO, LATAM Market Access

    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.

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  • Using a QMS to Qualify Your Suppliers

    2 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    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.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    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.

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  • Best Practices for Supplier Evaluation and Rationalization

    26 July, 2018 by Carla Frances Reed, President, New Creed

    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.

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  • Ensure Data Integrity With a Proactive Data Management Strategy

    24 July, 2018 by David Jensen, Staff Writer, MasterControl

    Data management technologies continue to evolve and improve the processes for collecting, storing and analyzing data. However, new technology rarely avoids growing pains. One dilemma regulated companies face with technology updates is maintaining data integrity. Regulatory guidelines for data integrity insist that all data and metadata remain intact and unaltered. This is a tall order when companies need to perform a large-scale data migration each time they update their data storage infrastructure. A good approach to effectively manage data and remain compliant with data integrity requirements is to develop a practical data management strategy around data storage and migration.

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  • Using the Newly-Approved Dietary Fibers in Supplements

    19 July, 2018 by Sarah Beale, Staff Writer, MasterControl

    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.

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