Dollar, money

Controlling Costs an Issue in Product Development

By MedTech Intelligence Staff

…these products in an efficient manner while keeping costs down, coordinating a range of internal departments, eliminating redundancy, and facilitating communication across an organization. During an upcoming MedTech Intelligence webinar,…

…these products in an efficient manner while keeping costs down, coordinating a range of internal departments, eliminating redundancy, and facilitating communication across an organization. During an upcoming MedTech Intelligence webinar,…

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

Protect Your Investments!

By Dr. Christopher Joseph Devine

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal…

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal…

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Mosquito, zika

Rocheā€™s Zika PCR Test Wins FDA Emergency Use Authorization

By MedTech Intelligence Staff

…been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. “The test has been…

…been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. “The test has been…

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Intuitive Surgical, robotic assisted surgery

The Transformation of Robotics in Asia

By Ames Gross

…consumer products. More recently, medtech companies have been seeking to develop robots in the healthcare industry. Although Western countries currently have the largest market for medical robots, Asian governments and…

…consumer products. More recently, medtech companies have been seeking to develop robots in the healthcare industry. Although Western countries currently have the largest market for medical robots, Asian governments and…

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Michael Lau, Steve Wilcox

Future Trends in Usability: Virtual Reality and Adaptive Systems

By Maria Fontanazza

…human factors, Insight Product Development Michael Lau, Ph.D., director of human factors at Insight Product Development [As far as] future trends: As companies realize the value of doing this entire…

…human factors, Insight Product Development Michael Lau, Ph.D., director of human factors at Insight Product Development [As far as] future trends: As companies realize the value of doing this entire…

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

Another CJO Convicted Courtesy of FDA and DOJ, Oh My!

By Dr. Christopher Joseph Devine

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and…

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and…

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ISO_13485

Quick List: The Update on ISO 13485:2016

By Maria Fontanazza

…72 times in the new standard as compared to only 16 times in the 2003 version), according to Roberta Goode, president and CEO of Goode Compliance International. During a recent…

…72 times in the new standard as compared to only 16 times in the 2003 version), according to Roberta Goode, president and CEO of Goode Compliance International. During a recent…

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ZimmerBiomet

Zimmer Biomet Boosts Musculoskeletal Diagnostics with CD Diagnostics Acquisition

By MedTech Intelligence Staff

Today Zimmer Biomet announced the acquisition of CD Diagnostics, a move that will further strengthen the company’s competitive position in the musculoskeletal market. The two companies formed a co-development and…

Today Zimmer Biomet announced the acquisition of CD Diagnostics, a move that will further strengthen the company’s competitive position in the musculoskeletal market. The two companies formed a co-development and…

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Daniel R. Matlis, Axendia
Soapbox

Iā€™m Watson, Please State the Nature of Your Medical Emergency

By Daniel R. Matlis

In the TV series Star Trek: Voyager, the ship’s Doctor was a computer program called the Emergency Medical Hologram (EMH). The EMH program was built into the starship’s sickbays as…

In the TV series Star Trek: Voyager, the ship’s Doctor was a computer program called the Emergency Medical Hologram (EMH). The EMH program was built into the starship’s sickbays as…

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Footsteps

FDA to Develop More Guidance on Pre-Request for Designation Process

By MedTech Intelligence Staff

comparisons to the RDF process: “In both cases, FDA’s assessment depends on sponsors providing a complete, clear, and detailed product description, which includes the product’s indication for use, its composition/ingredients,…

comparisons to the RDF process: “In both cases, FDA’s assessment depends on sponsors providing a complete, clear, and detailed product description, which includes the product’s indication for use, its composition/ingredients,…

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