• 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, Senior Clinical Research Specialist, IMARC

    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    A little over a year ago, the U.S. Federal Drug Administration (FDA) released its draft guidance (1) regarding a newer, skyrocketing segment of the medical device industry—that of Software as a Medical Device (SaMD).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, MasterControl

    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, Hyman, Phelps & McNamara

    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, Founder, Lean RAQA Systems, LLC

    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, Founder, 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, MasterControl

    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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  • The Use of "Poka Yoke" with Medical Device Design and Manufacturing

    17 May, 2011 by Jim Shore, Product and Process Improvement Leader, Dynisco

    The Poka Yoke method is something that improves your daily life; why not use it to make your product better, as well? The best solutions are simple, quick to implement and 100 times more effective than a 100-percent final inspection.

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  • Process Validation for Medical Devices

    17 April, 2017 Dan O'Leary, President, Ombu Enterprises, LLC

    Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.

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  • The Medical Device Design History File, Technical File / Design Dossier

    17 April, 2017 John Lincoln, Principal Consultant, J.E. Lincoln and Associates

    The United States Food and Drug Administration recognizes that with devices, the majority of serious problems are introduced during the design / change phases of development of new or changed products. Changes to existing products are addressed under Change Control, Engineering Change Orders, and similar required cGMP procedures. In the mid 1990s, it was recognized that the design of new product or major changes / line extensions to existing products was not well controlled. Recognizing this i

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  • Overview of ISO 13485 - Medical Device Quality Management System Requirements

    17 April, 2017 Betty Lane, CQMg, CQA

    Many people in the medical device industry do not know much more about quality systems than that they are required. This article provides an overview of medical device quality systems and then describes generally the requirements of the ISO 13485 international standard for medical devices quality management systems (QMS). Medical devices can be simple or complex, but all of these can benefit from being designed and manufactured under ISO 13485:2003 which is the most widely used medical device QM

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  • Failure Investigation: Treating the Root Cause, Not the Symptoms

    18 April, 2017 Karl Vahey, Director of Compliance, International RA/QA, Covidien

    Why should medical device manufacturers perform failure investigations? One reason is that it is a regulatory requirement. The Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the requirements for failure investigations. Performing effective failure investigations is also good business practice which can lead to reduction in scrap and rework, process improvements and the elimination of recurring issue

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  • Three Quality Management Tips to Avoid Death by CAPA - for Medical Devices Industry

    17 April, 2017 Ken Peterson

    It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you

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  • Medical Device Firms Experiencing 'Death by CAPA?'

    1 March, 2008 MasterControl

    Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine ris

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  • MasterControl.Cloud

    5 September, 2013 Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions

    What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl, I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it’s easy to see why so many consumers are confused. At its heart, the term Cloud has been a powerful marketing turn-of-phrase that has consolidated a large mix of technologies.

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  • SOP Training is Now “On-Line” But Are We Any More Compliant?

    17 September, 2013 Vivian Bringslimark, President, HPIS Consulting, Inc.

    Well, I’m told we are now more compliant with ensuring that only the most current SOP version is used for training. And yes, our Learning Management System provides us with curricula updates and “percent complete” and “percent overdue” notifications. LMSes and eDoc systems have given us efficient mechanisms to document that employees have completed their training curricula. But do they understand their procedures enough to perform them correctly back on the job? Just look at our human error deviations and training-related CAPAs. Are the numbers declining? According to an excerpt from the PDA’s Pharmaceutical Sci-Tech Discussion Group, there is “almost a 100% correlation between the percentage of read and understood SOPs and the number of compliance issues the company has.” (1) Has efficiency become the new metric for training and compliance? Using technology to read SOPs doesn’t guarantee learning transfer.

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  • Ten Points for Successful Use of TPLC Reports

    8 October, 2013 Maria Fagan, President, Regulatory & Quality Solutions LLC

    A Total Product Life Cycle (TPLC) Program ensures that quality is proactively designed into medical devices from concept to market, and during post market surveillance until device obsolescence.

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  • Innovation and the Quality Process

    8 October, 2013 Ken Peterson, Director of Quality and Consultation Services, MasterControl Inc.

    Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future? Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause. It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.

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