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Trend Report: Photonic Applications Offer Glimmer of Light

By Klaus Jopp

…coordinator of technology development at Olympus Surgical Technologies Europe, commented on new imaging procedures that improve the possibilities in microsurgery. “With Narrow Band Imaging (NBI), it is, for example, possible…

…coordinator of technology development at Olympus Surgical Technologies Europe, commented on new imaging procedures that improve the possibilities in microsurgery. “With Narrow Band Imaging (NBI), it is, for example, possible…

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Ameing for Asia

Medical Device Sourcing Trends in Asia

By Ames Gross

…that no single Indian manufacturer could produce all the components necessary to make our client’s complex component. Thus, the chosen Indian supplier will need to source some of the components…

…that no single Indian manufacturer could produce all the components necessary to make our client’s complex component. Thus, the chosen Indian supplier will need to source some of the components…

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Account for Quality Across Product Design

By Maria Fontanazza

…significant number of peer reviews, phase and sub- phase reviews. The biggest part of the quality [element] is how we communicate with our customer; we always set up mechanisms so…

…significant number of peer reviews, phase and sub- phase reviews. The biggest part of the quality [element] is how we communicate with our customer; we always set up mechanisms so…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

FDA Cites Failure to Assess Product Risk in Warning Letter

By Dr. Christopher Joseph Devine

…modification. For example, the new hazard of “cable fraying and exposed wires” that was identified in the summer of 2014 due to complaints was not added to the FMEA until…

…modification. For example, the new hazard of “cable fraying and exposed wires” that was identified in the summer of 2014 due to complaints was not added to the FMEA until…

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The intersection of complaint handling, risk management and postmarket surveillance in the medical device industry

The Integration of Complaint Handling and Risk Management

By Roberta Goode, Julie Cabezas

…do this in a compliant way, let’s start with the regulations that require risk management and complaint handling activities. Complaint Handling Regulations The requirements for complaint handling are fairly straightforward….

…do this in a compliant way, let’s start with the regulations that require risk management and complaint handling activities. Complaint Handling Regulations The requirements for complaint handling are fairly straightforward….

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Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers

Why the Hybrid Cloud is Practical for Medical Device Manufacturers

By Mika Javanainen

…many CIOs. Another common misconception many companies have is that their information is too classified to be stored in the cloud. The truth is, a “cloud-only” approach is not a…

…many CIOs. Another common misconception many companies have is that their information is too classified to be stored in the cloud. The truth is, a “cloud-only” approach is not a…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Endoscopes, Too Little and Too Late

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 12, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Fujifilm Medical Systems U.S.A., Inc., Warning Letter….

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 12, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Fujifilm Medical Systems U.S.A., Inc., Warning Letter….

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Kenneth Fine, president and cofounder of Proven Process

Obamacare and Great User Expectations Hit Device Design

By Maria Fontanazza

…political point of view, Obamacare has put a lot of pressure on the development of products. Ten years ago, companies could come out with a “me-too” product, obtain approval, and…

…political point of view, Obamacare has put a lot of pressure on the development of products. Ten years ago, companies could come out with a “me-too” product, obtain approval, and…

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Joachim Schaefer

Finding High-Tech Solutions in MedTech

By Joachim Schäfer

…diagnostics and optical components for laboratory equipment. Sample examinations traditionally conducted by pathologists under a microscope can now be performed with the push of a button. More compact, efficient, and…

…diagnostics and optical components for laboratory equipment. Sample examinations traditionally conducted by pathologists under a microscope can now be performed with the push of a button. More compact, efficient, and…

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Four Reasons to Use Additive Manufacturing in Medical Device Development

By Ron Belknap

…as cranial implants to decrease operation time and reduce complications, for example.5 The most common materials for end-use medical devices today are stereolithography (SLA) resins that are USP Class 6…

…as cranial implants to decrease operation time and reduce complications, for example.5 The most common materials for end-use medical devices today are stereolithography (SLA) resins that are USP Class 6…

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