Resolving the Challenges of Connectivity, Competition & Compliance for Modern Medical Device Makers

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For medical device manufacturers, new realities present favorable circumstances and worrisome challenges. For example, medical devices are now more integrated into inpatient, outpatient and home care. And technological advances continue to evolve medical device design and manufacturing. But as modern health reform increases patient connectivity, it also increases media scrutiny, leaving manufacturers with precious little

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Top 15 ISO 26262 Snafus

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What do golf and automotive software have in common? To the novice, seemingly nothing. However, the commonalities are more profound than expected. Consider common traits of golf and ISO 26262 as experienced by this author: • Both seem easy to start up, but complexities befuddle beginners • Both seem cheap to engage in initially, but

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Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

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Medical technology companies especially those developing medical devices are faced with a wide range of techniques for managing risk.  The hardest part is often deciding which specific techniques and data points need to be captured to demonstrate that all angles of risk analysis for the product have been accounted for. Today, many medtech companies are

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ISO 26262 and Automotive Electronics Development

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Compliance standards, especially those that involve relatively new functional safety elements, will likely add additional requirements to the development process. But ISO 26262, in particular, will add more than new requirements to the product life cycle for automotive hardware-software systems. This Functional Safety standard will act as a framework impacting integrated requirements traceability, risk management,

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The State Of Modern Product Delivery

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Are you delivering products that your customers really need, or what they say they want? According to fresh research from Jama and Forrester Consulting, 50% of business leaders are giving customers what they think they want but that fail to meet their real needs. Knowing the difference can be what separates tomorrow’s leaders from the

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A Modern Take On The Agile Manifesto

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When the Agile Manifesto was published in 2001, our workplace looked very different from how it does today. Despite major changes in how we work, our interpretation of the Manifesto hasn’t changed in over a decade. So what does today’s Agile look like? Do the values of the Manifesto still apply? How can we evolve

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