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Showing items tagged as Medical Device

  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

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  • January Tip: How to Choose and Use External Consultants

    23 January, 2018 by Jake Walton, Quality Manager

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

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  • Ensuring Quality In Medical Device Trials

    11 January, 2018 by Mary Lewis

    Manufacturers have used a quality systems approach to ensure consistency within their processes for years, but the FDA is now encouraging clinical researchers to take a similar approach to medical device trials.

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  • Software as a Medical Device: What Does It Mean and Why Should I Care?

    4 January, 2018 by Mike Rigert, Staff Writer, MasterControl

    A little over a year ago, the U.S. Federal Drug Administration (FDA) released its draft guidance (1) regarding a newer, skyrocketing segment of the medical device industry—that of Software as a Medical Device (SaMD). The guidance means to address the emergence of thousands of stand-alone, health-oriented software apps that fall into a gray area in terms of regulation. Obviously, SaMDs aren’t traditional medical devices, but neither are they Pokémon Go.

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  • Infographic: 10 Common Pains in Dossier Management for Med Device Firms

    30 November, 2017 by Cindy Fazzi, Staff Writer

    People say a picture is worth a thousand words. The 10 common pains in dossier management described in this infographic is worth ten thousand words given how much they affect the daily work of regulatory professionals and submission managers.

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  • FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device

    29 November, 2017 by Rachael E. Hunt & Allyson B. Mullen

    On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a significant number of comments, the final guidance is largely unchanged from the 2016 draft. Industry should also be comforted to know that the final guidance is also, at its core, very similar to the 1997 guidance – a welcome relief as compared to the 2011 draft guidance.

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  • FY2018 Increasing User Fees Affects Submission Strategy

    11 October, 2017 by Michelle Lott

    Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

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  • Three Ways to Accelerate Your Lean Journey

    4 October, 2017 by Dan Markovitz, Markovitz Consulting

    I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).

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  • Medical Device Firms: 3 Tips for Jumping Over the Dossier-Management Hurdle

    14 September, 2017 by Cindy Fazzi, Staff Writer

    For medical device companies, the ultimate goal is to commercialize their products, usually in more than one market. The road to a successful product launch in multiple markets is full of obstacles and one of the biggest hurdles is dossier management.

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  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by B. Christine Park; CQA, CQM/OE; Consultant

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 by UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 MasterControl

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

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  • Nuts and Bolts of 510(K) Submissions

    17 August, 2017 MasterControl

    A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

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  • Regulatory Strategies for AI and Emerging Technologies

    14 August, 2017 MasterControl

    Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.

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  • 6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

    8 August, 2017 Beth Pedersen

    Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers

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  • Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?

    3 August, 2017 MasterControl

    Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says 

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  • UDI as Med Device Product Tracking Software (Why That’s a Good Thing)

    1 August, 2017 Cindy Fazzi, Staff Writer

    When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?

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  • Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

    25 July, 2017 MasterControl

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

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  • 5 Trends Driving Disruption in the Med Device Industry in 2017

    20 July, 2017 MasterControl

    The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them.

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  • How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

    18 July, 2017 Greg Peckford, Founder, Quality Career Advancement

    Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

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