Design Control for medical devices can be understood as an integrated set of verifiable and demonstrable steps and practices undertaken by the manufacturers of these devices. Design Control for medical devices comprises a set of steps relating to the quality and consistency of medical devices, whose manufacturers take to ensure that:
- There is safety in the medical device under manufacture
- All the recommended and required steps and procedures that go into manufacturing…
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Added by Adam Fleming on October 31, 2017 at 6:08am —
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Joe Stuntz was most recently the Policy Lead for the White House Office of Management and Budget (OMB) Cyber and National Security unit, now he works with One World Identity. We spoke with Stuntz about cybersecurity threats and solutions.
In October 2017, One World Identity, an…
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Added by Adam Fleming on October 30, 2017 at 6:47am —
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Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations,…
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Added by Adam Fleming on October 27, 2017 at 6:07am —
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There's a lot of hoopla surrounding President Trump's new tax plan, which is reportedly considering capping pre-tax 401(k) contributions at $2,400 a year , a far cry from the current maximum contribution of $18,000 for 2017, and…
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Added by Adam Fleming on October 26, 2017 at 5:44am —
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Problems with Centrelink payments caused “extremely stressful” delays for some of Australia’s most disadvantaged groups this week, while newly released figures show complaints about the agency jumped by more than 50,000 in the last financial year alone.…
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Added by Adam Fleming on October 25, 2017 at 5:44am —
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Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing…
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Added by Adam Fleming on October 24, 2017 at 6:20am —
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There have been a lot of interesting reactions to the Equifax data breach. One of the most interesting for me is the criticism of the Equifax CISO’s lack of technical or cyber security education. She does have Bachelor’s and Master’s degrees in music composition as well as a resume that shows a work history at several companies also in the finance industry. This situation illustrates the challenge we all face in identifying qualified candidates.…
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Added by Adam Fleming on October 23, 2017 at 6:32am —
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In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated…
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Added by Adam Fleming on October 19, 2017 at 6:20am —
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After a week of back-to-back meetings in Washington, Oleksandr Danylyuk is tired. He gladly downs a cup of coffee before we turn on our microphones to discuss Ukraine’s economy. The affable forty-two-year old finance minister is one of the few reformers left in Ukraine’s Cabinet of Ministers and has a reputation as a doer. He’s in town for the International Monetary Fund’s and World Bank’s annual meetings.…
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Added by Adam Fleming on October 18, 2017 at 5:35am —
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The Statement on Standards for Accounting and Review Services (SSARS) is a section of the professional standards set out by The American Institute of CPA’s (AICPA), seeking to review earlier standards for reviewing and compiling financial statements and setting out the terms of engagement between the…
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Added by Adam Fleming on October 17, 2017 at 6:23am —
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Credit card surcharge was the bone of contention in an antitrust lawsuit filed 2005. As a result, the judgment in this case, which came in mid-2012, prohibited credit card surcharge in ten States. The implementation of their respective laws is underway in another 12 States.
Credit card regulations have traditionally opposed surcharging. Yet, companies have been devising ways by which they have sidestepped merchant rules and have continued to ensure that credit card surcharge gets…
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Added by Adam Fleming on October 16, 2017 at 6:13am —
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The financial regulators publish a listing of their exam initiatives for the upcoming year. Financial advisers use this listing to anticipate what thinking the regulators bring into a financial year, which will have a major bearing on the financial industry. This listing offers financial advisers an idea of what to expect during a particular financial year.
For instance, taking off from the backdrop of the financial crisis of 2007 to 2009; the…
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Added by Adam Fleming on October 13, 2017 at 6:04am —
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Microsoft Excel can be used to carry out a number of functions such as sorting, filtering, and subtotal to manage large lists of data. Yet, its MS Excel PivotTable is a very useful feature when it comes to analyzing all that data and doing it quickly. Its use is all the more pronounced when the user is required to quickly create a compact summary report (based on lots of data) without having to write complex formulas or rely on lengthy…
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Added by Adam Fleming on October 12, 2017 at 6:40am —
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Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out because computer systems used in highly regulated companies house very sensitive and valuable information.
Data relating to valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information are usually placed in…
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Added by Adam Fleming on October 10, 2017 at 6:26am —
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One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.…
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Added by Adam Fleming on October 9, 2017 at 6:16am —
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A third of UK small businesses are risking their online safety by operating at or below the “security poverty line,” according to new research from Duo Security.
The cybersecurity company partnered with YouGov to survey 1,0009 senior decision makers across the UK to determine how much they are spending on cybersecurity and whether government initiatives such as Cyber Essentials and Cyber Risk Aware have been effective at protecting SMBs from cyber…
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Added by Adam Fleming on October 6, 2017 at 6:12am —
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For any product that is being produced using the extrusion process; raw materials and their characteristics are the most important variable.
Grasp of why things happen as they do in the process and why the process and product being produced react as they do, can come about only when there is a basic understanding of the raw materials and how they flow, cook and potentially over-process.
Since different types of ingredients have different properties; each ingredient reacts very…
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Added by Adam Fleming on October 4, 2017 at 6:16am —
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With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.
Some freshmen even might worry about the…
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Added by Adam Fleming on October 3, 2017 at 6:39am —
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