• Medical Device - Articles / News


    It’s been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal CAPA system. Yet, managing a CAPA system remains a major challenge for many manufacturers. Let’s consider a few things that could help you improve your system.By Ken PetersonFull Article

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  • The Four Pillars of QSR Compliance

    17 April, 2017 Denise Dion, Senior Consultant, EduQuest, Inc.

    At first glance, FDA's Quality System Regulations (QSR) for medical devices - contained in 21 CFR 820 - may make your eyes cross and your stomach churn. The rules are intimidating, yes - but impossible to follow, no.

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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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  • The Medical Device Market in Japan: Worth its Weight in Gold?

    Marci Crane

    For medical device makers the device market in Japan is a literal gold mine.

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  • Management Review - Measuring the 'Heartbeat' of Your Quality Management System

    17 May, 2010 John Gagliardi, President of MidWest Process Innovation, LLC

    Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct these planned sessions. Most of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the Regulations (21 CFR, Part 820) and the standards (e.g. ISO 13485:2003 and ISO 9001:2000).

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  • Managing Outsourcing Operations Reduces Risk

    17 April, 2017 Steven Niedelman, former Deputy Associate Commissioner for Regulatory Operations and COO of the Office of Regulatory Affairs at FDA

    Recent problems associated with melamine in pet food, infant formula and milk products, ethylene glycol in toothpaste, salmonella in green peppers, and oversulfated chondroitin sulfate that mimics sodium heparin have prompted widespread news reports, which we have all seen, heard or read about, that affect many of the products we have grown to trust. In the case of the sodium heparin situation which resulted in hundreds of injuries and greater than eighty deaths, FDA shared the blame by failing

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  • Top Four Activities to Prepare for ISO 13485 Certification

    17 April, 2017 James Jardine

    The International Organization for Standardization (ISO) has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485:2003, which provides internationally recognized guidelines pertaining to quality management systems (QMS). Certification to ISO 13485 does not necessarily fulfill the requirements of regulatory agencies such as the U.S. Food and Drug Administration (FDA), but it will bring a company's

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  • 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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  • Med-tech Firms Face a Changing Economic, Regulatory Landscape

    6 December, 2010 Janet Moore, Minneapolis Star Tribune

    This article was first published in the Minneapolis Star Tribune on October 20, 2010.

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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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  • 19 Key Elements to Review for Effective Audits

    18 April, 2017 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o

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  • Product Risk Management Under ISO 14971:2007 and ICH Q9

    14 June, 2011 John E. Lincoln, J.E. Lincoln and Associates LLC

    Risk management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

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  • Product Development and Clinical Data Quality Management


    The product research, development and approval road is long, arduous, and costly, especially for pharmaceutical companies that are still reliant on manual processes and paper-based systems.  According to an ongoing study at Tufts (hyperlink -- http://csdd.tufts.edu/About/History.asp), the average cost of bringing a drug to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1 billion.  After a product is successfully launched,

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  • Top Benefits of Electronic GLP Management: What Non-Clinical Research Laboratories Should be the First to Know

    Diane Clements

    Industrialized nations, such as the United States, the European Union and Japan, have increasingly aging populations and are experiencing unprecedented growth in demands for healthcare and related technologies.

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  • Quality Management News


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