• From the Project Manager's Toolbox: Strategies for eCTD Marketing Application Submissions

    Rachel Cooper, Project Manager, Cato Research Ltd.

    Nothing may invoke fear in the heart of new, or even seasoned, regulatory project managers more than the preparation and submission of a marketing application in eCTD format for their company. At first glance, marketing application submissions can appear to be a tedious effort to manage with hundreds of documents and players, and requires orchestrating intricately detailed timelines and intertwined steps. A successful filing is possible but requires beginning with the end in mind by planning f

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  • Submissions Processes with Templates for Microsoft Word®

    18 April, 2017 Antoinette Azevedo

    As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a

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  • Transfer, Comparability and Co-validation

    12 August, 2011 Melissa J. Smith, Founder and Principal Consultant for MJQuality Solutions, LLC

    This article provides an overview of the elements of transfer with references to supportive documents that contain more detail on the areas of interest regarding transfer and validation.

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  • Please Don't Call Them CAPAs

    18 April, 2017 Denise Robitaille, RAB-QSA Certified Lead Assessor, Author and ASQ Certified

    I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separa

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  • Postmarket Management Team Restructuring Processes at CDRH

    17 April, 2017 MasterControl

    The safety of medical devices is a major concern for the FDA, manufacturers and consumers. One faulty drug or device can place lives at risk and ruin the public's trust. Recent events involving pharmaceuticals, medical devices, and combination products have heightened public awareness of product safety. The FDA's Center for Devices and Radiological Health ( CDRH ) responded to the public's concern by creating a new management system to improve the postmarket situation.

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  • Patience is a Virtue for Combination Product Manufacturers

    17 April, 2017 Marci Crane

    In a very real sense combination product manufacturers are changing the face of life science research and manufacturing. In fact, the near future may paint the combination products sector as the leading life science industry sector, while products like transdermal patches for depression, dental bone grafting material with a growth factor, absorbable collagen sponges with genetically engineered human protein, or a surgical mesh with antibiotic coating may become more common than their "less compl

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  • Making Medical Products Better, Faster, and Cheaper: What FDA's Critical Path Initiative Means for Consumers

    17 April, 2017 MasterControl

    Q. How do scientific discoveries affect the development of medical products? A. In recent years, there has been an explosion of scientific discoveries made possible through technologies such as genomics, advanced imaging, nanotechnology, and robotics. These scientific advances can help produce more and better medical products—not just drugs, but biologics such as vaccines, and devices such as pacemakers.But the efficiency for scientific discoveries being translated into medical prod

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  • Deadlines or Dead Projects

    17 April, 2017 William Wolenchuk, Jr., Customer Relations Manager/Medical Device Industry, MasterControl, Inc.

    For all medical device companies, managing a project can be a nightmare. Proper planning and managing of a project can make the difference between a successful product and a financial disaster. Most projects start out with good intentions. However, with improper planning up front, the project can quickly fall behind and run over budget for a number of reasons: poor or lack of requirements document; scope creep; long or missed timelines; employee commitment; change control; and tracking the pro

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  • CMS Launches New Competitive Bidding Program for DMEPOS

    17 April, 2017 MasterControl

    The Centers for Medicare and Medicaid Services (CMS) has opened the first round of competitive bidding for suppliers of Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) under a new acquisition program projected to save taxpayers $1 billion annually upon the program's full implementation in 2010.The new competitive acquisition program will initially apply to 10 of the top DMEPOS product categories within the 10 largest Metropolitan Statistical Areas (MSAs), exclud

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  • eMDR and Event Problem Code Changes: Are We There Yet?

    MasterControl

    Normally, "are we there yet?" is the annoying question kids, and some adults, ask during a drive to a summer vacation spot. As summer comes to an end, "are we there yet?" is also a good question for your company to consider with regard to two initiatives currently underway at FDA: eMDR and Event Problem Code changes.

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  • The Keys to European Compliance: An Informative Summary Regarding the European Medical Device Vigilance System Guidelines

    17 April, 2017 MasterControl

    The medical device industry, like most industries, is feeling the attractive pull of globalization. After all, global connections provide more business and combine innovative powers, two essential elements that are indispensable in successful med-device environments.

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  • For Medical Device Professionals - Is Your Executive Management Involved with Quality?

    13 September, 2011 Christine Park, Christine Park & Associates

    We've all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems:

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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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  • What is the FDA's Third-Party Inspection Program and pMAP?

    17 April, 2017 Gregor Dzialas, Third-Party Inspection Program Manager, TUV Rheinland

    Many medical device manufacturers do not realize they can save time, money and resources while satisfying inspection requirements by the FDA and other conformity assessment providers. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA introduced the Inspection by Accredited Persons Program or Third-Party Inspection Program. Under this program, eligible Class II and III medical device manufacturers can turn to an FDA-accredited third party to perform U.S. regulato

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  • FDA Announces 510(k) Changes

    22 March, 2011 MassDevice staff

    MassDevice.com is the online busines journal of the medical device industry. Visit www.massdevice.com for the latest FDA and medical device business news.

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  • FDA Postponing Annual Registration of Medical Device Establishments

    17 April, 2017 MasterControl

    The FDA announced in June that it is postponing the annual registration of registered medical device companies for 2008.

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  • Changes on the Horizon: The FDA’s Interactive Review Guidance

    17 April, 2017 MasterControl

    IIn the medical device industry, guidance documents set forth by the FDA are often the skeletal backbone for medical device design and development.  When a new guidance emerges, the med device industry pays attention. 

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  • Medical Device - Articles / News

    MasterControl

    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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