• Your Suppliers’ Risk Is Your Risk

    14 July, 2016 By Carrie Mantey

    In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.

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  • Aligning ISO 13485:2016 With Additional Standards and Regulations

    13 July, 2016 Marci Crane, Localization Manager, MasterControl

    MedTech Intelligence, a content hub for the medical device industry, provides a continuous stream of new business analysis, technological news, trend summaries, regulations, expert opinions and networking opportunities to medical device professionals. MedTech Intelligence will host the upcoming 13485:2016 conference on July 28-29, 2016 at Dentons, 1900 K Street NW, Washington D.C.

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  • MasterControl's Murray Defines Risk---and What It Isn't

    29 June, 2016 Marci Crane, Localization Manager, MasterControl

    For medical manufacturing professionals, the MD&M conferences and exhibits are some of the most valuable professional networking tools available. At MD&M East, medical manufacturing professionals, from the eastern United States and from areas spread across the world, meet together with regulatory, quality, compliance, and manufacturing experts to glean and share knowledge. Tracks covered over the course of the most recent conference, held June 13.-15, 2016, focused on “Market Value and Consumer Health, New Technologies, Big Data, and Mobile Product Risk.”

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  • CFDA Medical Device Software Regulation Undergoes Major Revision

    14 April, 2016 Beth Pedersen, Marketing Communications, MasterControl

    With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.

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  • Can’t-Miss Tips for Exposing Risk during Medical Device Development

    7 April, 2016 Lisa Weeks, MasterControl Communications

    Do you confuse risk analysis with risk assessment? Do you struggle to distinguish between a hazard and harm? Does the term risk management strike fear into your heart? If so, you’re not alone. Despite the publication of ISO 14971 in 2000 and, more recently, the inclusion of risk-based thinking among ISO 9001:2015 and ISO 13485:2016 requirements, many device manufacturers still struggle to understand, identify, assess and track risk across the product development lifecycle.

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  • The #1 Cause of Medical Device Recalls—and How to Avoid It

    8 March, 2016 Lisa Weeks, MasterControl Communications

    Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

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  • The Past, Present and Future of CAPA

    23 February, 2016 James Jardine, Marketing Communications Specialist, MasterControl

    Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.

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

    19 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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  • 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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  • Creating a High Performance and Low Risk Work Culture

    5 May, 2015 David Patrishkoff, President, E3- Extreme Enterprise Efficiency

    Most of us have heard the phrase: "Culture eats strategy for breakfast." It could also be restated as "Your actions speak louder than your words." This means that management can dream up any strategy they want to but their behaviors and actions are what creates the culture of an organization, not their strategy. Culture drives the efficiency of an organization's processes. The culture drives the success or failure of an organization. The culture is the product of leadership decisions or the lack

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  • Risk: 2015’s Most Valuable Player?

    23 April, 2015 Marci Crane, Marketing Communications, MasterControl

    For quality professionals, and especially those in quality management, there are often quality themes that seem to emerge from year to year. In 2000, the theme of process-driven quality was certainly salient and other various themes--though not necessarily new to quality management—seem to stand out as each year passes.

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  • Measuring Risk Management Outcomes

    3 February, 2015 Rod Farrar Director, Paladin Risk Management Services

    In his book Decision Making: Risk Management, Systems Thinking and Situation Awareness, Dr Alan McLucas introduces the concept of the Risk Management Paradox: “The task of managing risks effectively is confounded by a classical paradox. That is, if risks are being effectively managed as a matter of routine, there will be very few surprises. Nobody becomes aware of just how effective careful risk-management actions have proven to be. Nobody slaps the manager on the back and congratulates them for a job exceedingly well done. In stark contrast, however, if risks are managed poorly, the whole world lines up to say so.”

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  • Enter The Digital Risk Officer

    8 January, 2015 Nicola (Nick) Sanna President, Digital Risk Management Institute

    In the brave new world of digital risk management, a CISO would report up to a DRO who manages risk from a business perspective and works with peers in business operations, compliance and IT security.

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  • Risk Management: A Primer for Lean Quality Assurance

    6 January, 2015 Gina Guido-Redden Co-Founder, Coda Corp USA

    In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

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  • What Is Driving More Organizations to Plan an EQMS Adoption?

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

    In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?

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  • Establishing a Master Harms List: Streamlining Risk Management

    24 January, 2014 David Amor, CQA, MS Managing Partner, MEDgineering

    Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety. Drawing from multiple sources and inputs - whether from other hazard analyses, customer complaints, instructions for use or otherwise - the engineer may become overwhelmed with the plethora of available data and overlook some of the simpler and more frequently occurring harms. The preparation of an MHL gives you a leg up on the competition by giving you a “one-stop-shop” for all of your harms and eliminates the difficult task of assembling a coherent list from a multitude of sources.

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  • Transitioning from an FMEA Risk Analysis to a Total Risk Management System

    31 January, 2013 Richard Vincins, Vice President, Quality Assurance Consulting, Emergo Group

    Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk

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  • Regulations Vary Worldwide but Risk Management is Common Demoninator

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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  • Uncertainty and Risk: Providing Value for Stakeholders

    10 July, 2013 Greg Hutchins, Principal Engineer, Quality + Engineering (Q+E)

    In Against the Gods: The Remarkable Story of Risk, the author says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By consciously or unconsciously calculating probabilities, auditors make intelligent decisions about business processes. First let’s look at a few definitions of risk.

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