Showing items tagged as Medical Device

  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • Quality Pros & the Oscars: Films to See Based on Your Personality

    16 February, 2017 Cindy Fazzi, Staff Writer, MasterControl

    It’s Oscar season! From Seattle to Shanghai, movie fans are talking about their favorites, and maybe betting in their Academy Award office pool or its equivalent overseas. Watching Hollywood films is the world’s favorite pastime, judging by the U.S. film industry’s box-office revenues, which exceeded $11 billion in 2016 (1).

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  • Your Top 10 Questions About ISO 13485:2016—Answered!

    2 February, 2017 by Lisa Weeks, Staff Writer, MasterControl

    In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise

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  • 2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

    2 March, 2017 Marci Crane, Staff Writer, MasterControl

    For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of

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  • FDA Eager to be Innovative Partner with Expedited Access Pathway

    16 March, 2017 David Jensen, Staff Writer, MasterControl

    Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

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  • The Most Important Four-Letter Words in ISO 9001:2015

    21 March, 2017 by Christine Park, Consultant, Christine Park & Associates

    Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….

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  • 5 Warning Signs of Diminishing Supplier Quality

    30 March, 2017 David Butcher, Staff Writer, MasterControl

    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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  • How to Practice Quality Management in Your Personal Life

    4 April, 2017 Paul Sanderson, Solutions Consultants Manager, MasterControl

    “Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

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  • Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

    11 April, 2017 David Jensen, Staff Writer, MasterControl

    I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

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  • Human Factors: Why it is Critical in Designing Medical Devices

    18 April, 2017 David Jensen, Staff Writer, MasterControl

    “Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    24 April, 2017 Cindy Fazzi, Staff Writer, MasterControl

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    27 April, 2017 by Drew Locher, President, Change Management Associates

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

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  • Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

    8 June, 2017 by Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.

    While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?

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  • Free Webinar: What the New European Med Device Regulation Means

    22 June, 2017 by Cindy Fazzi, Staff Writer, MasterControl

    The European Parliament recently adopted a stricter, more extensive Medical Device Regulation (MDR) to replace the Medical Device Directives (MDD). It will affect all manufacturers selling devices in the European Union. What does the new regulation mean for device manufacturers? Will it make life harder and increase costs for them?

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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 by Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

     At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines

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  • An Exciting Time in Life Sciences: Touching Stories from a Life-Improving Industry

    29 June, 2017 by Marci Crane, Staff Writer, MasterControl

    A recent industry outlook for the life sciences industry published by Deloitte mentions opportunities and concerns facing the life sciences industry.

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