• Overcoming the Top Three Project Management Challenges

    18 April, 2017 MasterControl

    During the course of the development of a new medical device, project managers inevitably come across three major obstacles to efficient project management: regulatory constraints, resource limitations, and on-time delivery. Prevailing over these challenges may have less to do with better planning and improved project execution and more to do with the management systems employed during the product development cycle.

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  • Global Harmonization Task Force Final Document: Standards in the Assessment of Medical Devices

    18 April, 2017 Marci Crane

    The following article is a Q&A regarding the release of the Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices (acknowledged in this article as the RSAMD final document).1 Q: What is the Global Harmonization Task Force (GHTF)? A: The GHTF is a voluntary group that consists of trade association and medical device authorities from the USA, Canada, Europe, Japan and Australia. Q: Who is the authoring group for the RSAMD final document

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  • Supply Chain Oversight is the FDA's Next Area of Concern

    4 January, 2011 Alan Schwartz, Consultant, mdi Consultants, Inc., and Former Supervisor of Field Operations, USA FDA

    The FDA recently stated its intent to stretch its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to take bigger steps toward managing suppliers and tightening up the supply chain. Carmelo Rosa, an FDA compliance officer, explains that "Currently, the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations but it is looking at other options."

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  • Four Reasons Why You Should Consider Joining the FDA's STED Pilot Program

    17 April, 2017 Matthew M. Lowe

    Wouldn't it be great to launch your next product globally? It certainly makes good business sense. But for medical device manufacturers, this is an unreasonable goal because different countries and geographical regions require different regulatory submission formats. So, a 510(k) that has been cleared by the FDA is not applicable in Australia or France because of unique format requirements in those countries. What this means is that a medical device firm's schedule for product release must be ha

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  • 'Standard Work' for Problem Solving

    17 April, 2017 Chris Tsai, President of Global Productivity, Inc. and Certified Six Sigma Black Belt

    When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem (i.e. transcription error, typo, missing part) receive the same level of rigor as a complex, multi-variate problem? Are the appropriate problem solving team resources involved and do they all have a consistent expectation of roles & responsibilities? If you're a medical device manufacturer, are investigations and the resulting documentation providing the objective evidence needed to demonst

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  • Creating and Auditing a Global Quality System

    17 April, 2017 Nancy Singer, President, Compliance-Alliance

    Medical device and drug firms with multi-national facilities have many challenges. They need to comply with numerous regulatory requirements. To increase the efficiency of their operations, many firms are creating a globally harmonized quality system for their entire organization, and they are using internal and supplier audits to maintain compliance with regulatory requirements.

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  • The Sentinel Initiative: Will it finally result in postmarket protection and premarket improvement?

    Marci Crane

    In June 2008 FDANews released an article describing CDRH's top priority which according to the article's summary is a "new postmarket initiative." Also according to the summary, postmarket issues "have taken precedence over premarket [issues]" and have garnered "the first-place slot for the center's priorities."1

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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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  • Improving Your Quality Management System Step-By-Step - For Medical Devices Industry

    MasterControl

    Medical device firms must contend not only with stiff competition in the marketplace, but also with strict FDA regulations and ISO standards. Most medical device companies recognize the importance of an effective and efficient quality management system (QMS) to help gain competitive advantage and ensure regulatory compliance. If your firm is one of those companies, here are some tips for you.Initial AssessmentLet's take the example of Medical Device Company X, which hired a third-party ISO/cGMP-

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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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  • Proposed Changes to the 510(k) Process: 10 Recommendations for Strengthening the 510(k) Program

    5 December, 2010 Claudette Kile, Principal Consultant, BMP Group

    Recently released recommendations for changes to the Food and Drug Administration's (FDA) 510(k) clearance program for class II medical devices has been a hot topic within the medical device industry. The 510(k) notification process uses predicate devices that the Center for Devices and Radiological Health (CDRH) at FDA has previously cleared for market release through the 510(k) notification process. New devices submitted for clearance must show substantial equivalence to predicate (cleared) de

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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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