• Uncertain Times for Medical Devices - Regulatory and Clinical Advice

    17 April, 2017 Ron Warren, Principal Consultant, Regulatory Services, Medical Device Consultants, Inc.

    There is no shortage of discouraging news these days for the medical device industry. We continue to hear how the recession is curtailing investment and venture funding of new medical technologies. Many start-ups find they are unable to attract new funding for projects or have to delay major expenditures for product development. Moreover, FDA is under new leadership and promising increased enforcement in food and drug programs and is taking a hard look at device programs, particularly the 510

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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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  • Off-Label Promotion of Medical Devices: Seeking Clues from the Past to Protect Against Increased Enforcement in the Future

    17 April, 2017 Amy Colvin and James R. Ravitz

    Pharmaceutical companies that promote their products for off-label use continue to be the subject of intense regulatory scrutiny. But they are no longer alone. Recent statements by government prosecutors suggest an increased focus on the sales and marketing practices of device companies. The medical device industry should expect heightened scrutiny from the "usual" actors, including the Food and Drug Administration (FDA), the Office of the Inspector General (OIG) of the Department of Health and

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  • FDA Report Shows Challenges of Post-Market Monitoring of Medical Devices - MasterControl News

    17 April, 2017 MasterControl

    With about 15,000 medical device manufacturers selling nearly 100,000 products in the U.S. market, post-market monitoring of medical device safety remains a major challenge for the FDA.

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  • Postmarket Surveillance: Are You Prepared for FDA's New Priority?

    17 April, 2017 Elaine H. Tseng, King & Spalding LLP's FDA/Healthcare Group

    FDA is focused on improving postmarket surveillance (PS) to optimize the identification, analysis, and use of postmarket information about medical devices. As such, manufacturers should ensure a thorough understanding of PS requirements and authorities, and can also benefit from robust PS practices.

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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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  • Quality Audit: Most Common Pitfall for Medical Device Firms

    17 April, 2017 MasterControl

    The FDA requires medical device firms to conduct quality audits to help ensure product quality and safety, but many firms apparently don't comply. Lack of audit procedures or audit schedule are among the most common problems for these companies during inspections, according to an FDA medical device specialist.

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  • Quality Audit: Most Common Pitfall for Medical Device Firms

    17 April, 2017 MasterControl

    The FDA requires medical device firms to conduct quality audits to help ensure product quality and safety, but many firms apparently don't comply. Lack of audit procedures or audit schedule are among the most common problems for these companies during inspections, according to an FDA medical device specialist.

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  • Quality By Design, Total Product Life Cycle, and Seven Ways to Improve Design Controls for an FDA Inspection

    17 April, 2017 Lori Carr, Regulatory Consultant

    With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must in the world in which we live.

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  • FDA 21 CFR Part 11 And Predicate Rules Article

    14 April, 2017 David Ade

    Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

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  • Final FDA Rule on Dietary Supplements (21 CFR Part 111) Guidance

    14 April, 2017 Sharon Phillips

    In June 2007, the U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.

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  • Making the Transition to an E-System

    14 April, 2017 Janet Gough, Course Director, Center for Professional Innovation and Education

    This is the first part of a two part article.

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  • The Cost of Quality: a Study on Life Sciences

    14 April, 2017 MasterControl

    The Cost of Quality: a Study on Life SciencesThe Cost of Quality: a Study on Life Sciences webinar presents findings from the published report, The Cost of Quality: a Study on Life Sciences, a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers. According to the report, "Aberdeen surveyed 169 [&helli

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  • Study: High-Performing Manufacturers Enforce Enterprise-Wide Quality Procedures as Top Business Strategy

    14 April, 2017 MasterControl

    A recent survey of 176 manufacturers throughout the world shows that more than half of best-in-class companies enforce enterprise-wide quality procedures as a top business strategy.These high-performing manufacturers take a more disciplined approach toward enforcing quality procedures, and are farther along in closing the quality loop than poorer performing companies, according to a benchmark study by the Aberdeen Group, a leading research group for the technology-driven value chain.The s

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  • 21 CFR Part 11: What's New? GxP Lifeline

    14 April, 2017 MasterControl

    The anticipation over a new 21 CFR Part 11 and a new companion guidance for compliance is waning because of persistent speculation within the industry that the FDA is not ready to release the documents until later this year or perhaps next year.Ever since the agency issued a nonbinding guidance on Part 11's scope and application in 2003, the industry was rife with talk about the need for a better guidance, and perhaps a new and better regulation altogether. Four years later, there is neither a n

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  • Adopting Technology In The Life Science Industry Article

    14 April, 2017 Curt Porritt

    By Curt Porritt

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  • How to Solve the Top Five Complaint-Handling Challenges

    14 April, 2017 MasterControl

    Consumer complaints are at the heart of every product recall. Whether it's Merck's voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints.The reporting of side effects or adverse events is incorporated in FDA regulations. The agency operates MedWatch, a safety information and adverse-event reporting program that allows health-care professionals and the public to report serious probl

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  • Shook Up Without QA: A Brief Look At The 24th Annual SQA Meeting

    14 April, 2017 MasterControl

    Another well-attended and enlightening annual meeting of the Society of Quality Assurance (SQA) was held on April 20-25, 2008 in Memphis, Tennessee. In keeping up with the theme of "All Shook Up Without QA," the meeting offered the state-of-the-art experience in promoting and advancing the principles and knowledge of quality assurance essential to regulated research in the human, animal and environmental health sciences. For those that have never attended an SQA annual meeting, this year's meeti

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  • How to Solve the Top Five Batch Record Challenges

    14 April, 2017 Oliver Wolf

    By Oliver Wolf

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  • Solutions for Most Common Change Control Issues Face by Life Science Companies

    14 April, 2017 MasterControl

    1. Inefficient System of Communication. You need effective communication to be able to implement change properly. For a company that relies on a paper-based or partially electronic system, this is the typical scenario: Once or twice a week, up to 15 people who constitute the Change Control Board meet for two hours each time to discuss engineering and other document changes. Before and after each meeting, documents are routed using the inter-office mail system or via e-mail. The problem wi

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