Robert Dostert, DNV

Ask the Expert: The EU Medical Device Regulation (MDR) – Is Anyone Ready and Where Are We Headed?

By Robert Dostert

The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look. There…

The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look. There…

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James Thompson, Siemens

Ask the Expert: Leveraging the Digital Infrastructure to Align with Best Practices and Accelerate Growth

By MedTech Intelligence Staff

…at high quality that achieves regulatory compliance. In this issue of Ask the Experts, James Thompson, responds to questions about how digital infrastructure is leading the way in medical device…

…at high quality that achieves regulatory compliance. In this issue of Ask the Experts, James Thompson, responds to questions about how digital infrastructure is leading the way in medical device…

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Aleksey Baldygin, KRUSS

Ask the Expert: Surface Science for Superior Biocompatibility and Well-formed Bonds

By Aleksey Baldygin, Ph.D.

…allowing OEMs to innovate with confidence. In this issue of Ask the Experts, KRÜSS Technical Consultant, Aleksey Baldygin, respond to questions about how surface science is leading the way in…

…allowing OEMs to innovate with confidence. In this issue of Ask the Experts, KRÜSS Technical Consultant, Aleksey Baldygin, respond to questions about how surface science is leading the way in…

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Autoinjector

Optimize Combination Products: Select a Platform Drug Delivery Device that Reflects Good Human Factors Engineering

By Erin Davis, Allison Strochlic

…device developer should have conducted user research such as observations, interviews, focus groups, and/or surveys to identify and understand user needs. If the developer conducted such research, ask about participants’…

…device developer should have conducted user research such as observations, interviews, focus groups, and/or surveys to identify and understand user needs. If the developer conducted such research, ask about participants’…

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Rafael Mazuz, Diligence Wound Care Global

How to Assess and Select Biomedical Distributors in Emerging and Frontier Markets

By Rafael Mazuz

…key question that clients ask is: How might we quickly yet sustainably capture and grow our market share in the developing markets? While setting up local subsidiaries to provide all…

…key question that clients ask is: How might we quickly yet sustainably capture and grow our market share in the developing markets? While setting up local subsidiaries to provide all…

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

Bayer’s New Headache

By Dr. Christopher Joseph Devine

ask the doctor the million-dollar question: “What in the heck does Aspirin have to do with medical devices?” In the case of Bayer, the executive management team is probably throwing…

ask the doctor the million-dollar question: “What in the heck does Aspirin have to do with medical devices?” In the case of Bayer, the executive management team is probably throwing…

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Proto Labs, rapid manufacturing

Ask the Expert: Get to Trials Faster with Rapid Manufacturing

Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes and production parts including device handles, housings, strain reliefs and other medical application components. Tony…

Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes and production parts including device handles, housings, strain reliefs and other medical application components. Tony…

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