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Showing items tagged as medical devices

  • Revisiting CAPA for a More Modern (and Effective) Approach

    17 October, 2017 by Peter Knauer

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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  • Medical Device Firms: 3 Tips for Jumping Over the Dossier-Management Hurdle

    14 September, 2017 by Cindy Fazzi, Staff Writer

    For medical device companies, the ultimate goal is to commercialize their products, usually in more than one market. The road to a successful product launch in multiple markets is full of obstacles and one of the biggest hurdles is dossier management.

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  • Understanding FDA’s UDI Guidance: The Key to Compliance

    13 June, 2017 Beth Pedersen

    The latter half of 2016 saw the second highest number of U.S. medical device recalls since 2000 with 650 medical devices and over 180 million units pulled from the market, according to Stericycle ExpertSOLUTIONS’

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  • 5 Warning Signs of Diminishing Supplier Quality

    30 March, 2017 David Butcher, Staff Writer

    supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

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  • 5 Reasons Why Leslie Knope Should Manage Your SOPs

    24 January, 2017 David Jensen, Marketing Communications

    Compliance observations and warning letters regarding standard operating procedures (SOPs)—or the lack of—in life sciences manufacturing facilities are as common as fruitcake during the holidays. How can medical device and pharmaceutical manufacturers hope to reduce the exorbitant number of documentation infractions? Get Leslie Knope to manage your SOPs.

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  • Top 7 Takeaways from AdvaMed 2016

    26 October, 2016 Lisa Weeks, Marketing Communications Specialist MasterControl

    Last week, I attended AdvaMed 2016, the leading medtech conference in North America. This year’s conference was the biggest yet, with more than 2,650 medtech professionals descending on Minneapolis for three days (October 17-19) of educational sessions, lively panel discussions and inspiring patient stories. As the birthplace of the modern medical device, and home to nearly 1,000 health technology companies, Minneapolis was a suitable host location to celebrate the tenth anniversary of the confe

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  • The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA

    23 June, 2016 Winston Brown, VP of Global Quality & Regulatory Affairs Phillips-Medisize

    The drug-device combination product market is growing at a rapid pace. By 2019, it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012.(1) This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained. To avoid unnecessary delays and gain speed to market through ‘right the first time’ regulatory submissions for a combination product, sponsor companies must understand the various pathways for which a combination product can travel. In addition, companies must also understand their own products enough to be able to discern what specific regulatory path it would follow. This not only preserves the relationship between sponsors and regulators, but it also ensures safe and effective medical treatments reach patients in a timely manner.

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  • ISO 13485:2016 What are the Changes About?

    3 March, 2016 Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

    21 January, 2016 Mark Leimbeck, Program Manager UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from basic safety (only) to include essential performance; and second, introduction of a requirement for assessment of the risk management process applied by manufacturers in developing their medical devices.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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  • The Bright Future of Quality and Compliance

    14 May, 2015 Craig Gygi, Executive Vice President, Operations, MasterControl Inc.

    Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?

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  • The ISO 9001: 2015 Change Train is Gathering Steam

    6 May, 2015 Robyn Barnes, Marketing Communications, MasterControl

    ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

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  • The Perks of Pursuing a Career in Quality Management

    17 February, 2015 Greg Peckford, Founder, Quality Career Advancement

    It is a bit of a mystery to me that more is not made of the personal career advantages and knowledge gained from performing procedural assessments, audits and other quality management related functions. For me personally, this type of activity has been one of the key factors in my career progression and advancement.

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  • Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

    23 December, 2014 Cheryl Wagoner, Principal Consultant/Owner, Wagoner Consulting LLC

    As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices,

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  • MasterControl Says “Go Live” to Localized Websites

    6 November, 2014 Jason Clegg, Director of Marketing, MasterControl

    At its core, website translation is a process that allows everyone across the globe to access the same opportunities and/or products in their own languages. This is especially important to companies like MasterControl that are expanding in to international markets.

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  • INFOGRAPHIC: U.S. Manufacturing Facts and Figures

    7 October, 2014 David R. Butcher, Marketing Communications, MasterControl

    Last Friday marked the third annual Manufacturing Day (MFG DAY), a growing grassroots movement of manufacturers dedicated to bringing attention to modern North American manufacturing and empowering the professionals who compose it. Here we highlight some of the contributions of U.S. manufacturers to the nation’s economy.

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