ECRI Instiute

Testing Devices Critical Part of Improving Patient Safety

By Maria Fontanazza

…a myriad of services to the broader healthcare industry, from healthcare facilities to nurses and physicians to medical device companies (which ECRI calls “suppliers”). With the objective of improving patient…

…a myriad of services to the broader healthcare industry, from healthcare facilities to nurses and physicians to medical device companies (which ECRI calls “suppliers”). With the objective of improving patient…

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David Amor, Medgineering
Soapbox

Evaluate a Companyā€™s Regulatory and Quality ā€˜Healthā€™ Before Investing

By David Amor

…QMS and anticipate future financial commitment to ensuring the company has a robust QMS in place. Evaluate quality and regulatory resources at the target company Pop quiz: Who is the…

…QMS and anticipate future financial commitment to ensuring the company has a robust QMS in place. Evaluate quality and regulatory resources at the target company Pop quiz: Who is the…

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Dollar, money

Combination Products to Get Part of $5.1 Billion Requested FDA Budget

By MedTech Intelligence Staff

…center will accelerate the development of new combination products, along with supporting development of companion diagnostic tests and using combination products to treat cancer. FDA also wants more than $3…

…center will accelerate the development of new combination products, along with supporting development of companion diagnostic tests and using combination products to treat cancer. FDA also wants more than $3…

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ECRI, duodenoscopes, endoscopes

Why Duodenoscopes Are So Tough to Clean

By Maria Fontanazza

…get the cleaning done—and how fast. During a recent visit to ECRI (Plymouth Meeting, PA), Lavanchy explained the complex design of the devices and why they can be so difficult…

…get the cleaning done—and how fast. During a recent visit to ECRI (Plymouth Meeting, PA), Lavanchy explained the complex design of the devices and why they can be so difficult…

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

Significant Design Change Requires FDA Notification

By Dr. Christopher Joseph Devine

…one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of…

…one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of…

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Ed Dougherty, Dentons

Developing an mHealth Technology? Answer These Questions First

By Maria Fontanazza

…satisfied can be a complex process. Last week industry experts gathered at a MedTech Intelligence conference to discuss the challenges facing mHealth and how device manufacturers should work together to…

…satisfied can be a complex process. Last week industry experts gathered at a MedTech Intelligence conference to discuss the challenges facing mHealth and how device manufacturers should work together to…

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Human Factors, Combination Products Focus of Latest FDA Guidances

By MedTech Intelligence Staff

…states. The draft guidance is open for comments until May 3, 2016. The agency addressed human factors in combination products in a draft guidance released last week. Human Factors Studies…

…states. The draft guidance is open for comments until May 3, 2016. The agency addressed human factors in combination products in a draft guidance released last week. Human Factors Studies…

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Insulet, OmniPod

Beyond Diabetes, Insulet Explores Viable Smart Drug Delivery

By Maria Fontanazza

…applications for several years. Expansion within the combination products realm involves investigating a complex set of competencies, from device-drug compatibility to ensuring precise drug delivery within a specific timeframe. In…

…applications for several years. Expansion within the combination products realm involves investigating a complex set of competencies, from device-drug compatibility to ensuring precise drug delivery within a specific timeframe. In…

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Ameing for Asia

Exporting More Internationally? Focus On Asia

By Ames Gross

…to mid-size medtech companies that are seeking to grow their international business and are exporting more products. From now until to the foreseeable future, the money is in Asia (and…

…to mid-size medtech companies that are seeking to grow their international business and are exporting more products. From now until to the foreseeable future, the money is in Asia (and…

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Soapbox

Want to Be a Medical Device Entrepreneur?

By Scott Phillips

…Eventually he was able to persuade a small company, Edwards Laboratories, to make them commercially. From there, Fogarty founded 33 medical device companies and a venture capital company while maintaining…

…Eventually he was able to persuade a small company, Edwards Laboratories, to make them commercially. From there, Fogarty founded 33 medical device companies and a venture capital company while maintaining…

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