• Validating Electronic Spreadsheets or Automated Forms

    17 April, 2017 Louis Rutledge, Manager of Validation Services and Solutions, MasterControl

    Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries. From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel member not familiar with c

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  • Creating Value Solutions Through Assessment and Risk Reduction

    17 April, 2017 Chris Ward and Thomas Menighan, RPH, MBA, SynTegra Solutions

    Auditing is a more formalized assessment process. Whether we are assessing vendors like software developers whose products are used in the automated processes for manufacturing of pharmaceuticals or medical devices or the less technologically driven processes like pharmaceutical distribution channels for supply chain integrity; the process of inspection can help create useful data to support development of technology for specific uses. These audits also stimulate the utilization of technology

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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 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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  • 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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  • 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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  • 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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  • 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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