Joachim Schaefer
Soapbox

Medtech Trends: Digitization, Smart Technologies and 3-D in the OR

By Joachim SchƤfer

communication technology, medical furniture and specialist furnishings for hospitals and physicians’ offices. The COMPAMED trade fair will be held concurrently with MEDICA. With 18,800 visitors last year, COMPAMED broke its…

communication technology, medical furniture and specialist furnishings for hospitals and physicians’ offices. The COMPAMED trade fair will be held concurrently with MEDICA. With 18,800 visitors last year, COMPAMED broke its…

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Brian Williams, PwC

Transformation of New Healthcare Model Demands More Medtech Partnerships

By Maria Fontanazza

…medtech companies are software companies, app developers or consumer-focused companies. There are new entrants with well-developed skills that lack the clinical insight and capabilities medtech companies offer. By collaborating and…

…medtech companies are software companies, app developers or consumer-focused companies. There are new entrants with well-developed skills that lack the clinical insight and capabilities medtech companies offer. By collaborating and…

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

Pins and Needles

By Dr. Christopher Joseph Devine

…reviewed product labeling for the SkinPen II, including your firm’s websites located at http://bellusmedical.com/products/skinpen, http://skinpen.com/ and https://www.youtube.com/watch?v=zWRwhi9Yjrc, brochures, and pamphlets, which revealed that the SkinPen II is an automated, non-surgical…

…reviewed product labeling for the SkinPen II, including your firm’s websites located at http://bellusmedical.com/products/skinpen, http://skinpen.com/ and https://www.youtube.com/watch?v=zWRwhi9Yjrc, brochures, and pamphlets, which revealed that the SkinPen II is an automated, non-surgical…

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Ameing for Asia

Chinese Clinical Trials: New GCP Requirements

By Ames Gross

…to the composition and responsibilities of the ethics committee. According to Article 30, there must be at least five members of the committee (with both genders represented) of both medical…

…to the composition and responsibilities of the ethics committee. According to Article 30, there must be at least five members of the committee (with both genders represented) of both medical…

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Medical devices market in Russia, Intertek

Five Steps to Medical Device Commercialization

By Michael Lynch

…case of a 510(k) or PMA, the associated fee. After submission, the FDA will conduct an administrative review to determine if the submission is sufficiently complete. FDA staff will communicate…

…case of a 510(k) or PMA, the associated fee. After submission, the FDA will conduct an administrative review to determine if the submission is sufficiently complete. FDA staff will communicate…

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ICU Medical to Acquire Hospiraā€™s Infusion Systems for $1 Billion

By MedTech Intelligence Staff

…infusion systems business includes IV pumps, solutions and devices. The union is expected to create a pure-play infusion therapy company, competitive in the U.S. and global market (with direct operations…

…infusion systems business includes IV pumps, solutions and devices. The union is expected to create a pure-play infusion therapy company, competitive in the U.S. and global market (with direct operations…

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

One and Done

By Dr. Christopher Joseph Devine

…or on 11/17/15 due to the afore-mentioned syringe issue.” 21 CFR, Part 820.30(g) (g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation…

…or on 11/17/15 due to the afore-mentioned syringe issue.” 21 CFR, Part 820.30(g) (g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation…

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John Walmsley, Starfish Medical

Observing the Human Factor

By John Walmsley

…easily adjusted in a way that would be much harder if most design activities were completed before testing. Faced with a completed device that the user needs to engage with…

…easily adjusted in a way that would be much harder if most design activities were completed before testing. Faced with a completed device that the user needs to engage with…

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Pediatric technologies

Technologies for Smaller Patients Ready for Big Prize

By MedTech Intelligence Staff

This Saturday, October 8, the winners of the fourth annual Pediatric Surgical Innovation Symposium competition will be announced. Why is this important? Well, it’s no secret that the pediatrics market…

This Saturday, October 8, the winners of the fourth annual Pediatric Surgical Innovation Symposium competition will be announced. Why is this important? Well, it’s no secret that the pediatrics market…

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4 Facts about Industry 4.0 Medical Device Manufacturers Canā€™t Ignore

By John Dzelme

…nutshell will be comprised of a combination of advanced software, sensors and communication technology. Machines on the shop floor will be connected to wired and wireless networks via embedded sensors…

…nutshell will be comprised of a combination of advanced software, sensors and communication technology. Machines on the shop floor will be connected to wired and wireless networks via embedded sensors…

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