Medical device recall

Medical Device Recalls Down Nearly 10%

By MedTech Intelligence Staff

Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for

Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for

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gavel

Medical Device Software & Products Liability: Interoperability (Part III)

By Sara E. Dyson, Esq.

…or combined with products created by several other manufacturers. In other instances, companies set out to create interoperable products in collaboration with partner-manufacturers. For example, consider the relationship between Stryker…

…or combined with products created by several other manufacturers. In other instances, companies set out to create interoperable products in collaboration with partner-manufacturers. For example, consider the relationship between Stryker…

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Alert

Pentax Medical Recalls Certain Duodenoscopes

By MedTech Intelligence Staff

…facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website. https://medtechintelligence.com/news_article/why-duodenoscopes-are-so-tough-to-clean/  …

…facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website. https://medtechintelligence.com/news_article/why-duodenoscopes-are-so-tough-to-clean/  …

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RJ Palmero, Innovative Publishing

RJ Palermo Joins Innovative Publishing Company Team

By MedTech Intelligence Staff

…the company’s food safety medical device and cannabis industries, working on both conference sponsorships and booth sales. RJ will work side by side with Marc Spector, Director of Sales –…

…the company’s food safety medical device and cannabis industries, working on both conference sponsorships and booth sales. RJ will work side by side with Marc Spector, Director of Sales –…

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European Union Flag

The New MDR: Opportunity Knocks

By Peter Rose

…is achieved This opens up commercial opportunities for MDR compliance pioneers, who will be able to serve the resulting market segments while their competitors remain excluded Our research combined a…

…is achieved This opens up commercial opportunities for MDR compliance pioneers, who will be able to serve the resulting market segments while their competitors remain excluded Our research combined a…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Chinaā€™s Ophthalmology Market: Challenges For Foreign Device Makers

By Ames Gross

China’s ophthalmic market is set to grow rapidly in the coming years, driven by the country’s quickly aging population. Market Scope forecasts this year that China’s $2.7 billion ophthalmic market…

China’s ophthalmic market is set to grow rapidly in the coming years, driven by the country’s quickly aging population. Market Scope forecasts this year that China’s $2.7 billion ophthalmic market…

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

Failure to Respond, Oh Boy

By Dr. Christopher Joseph Devine

…the compliance lapse occurred (a.k.a. root cause). If the compliance issue impacts product already entered into commerce, the FDA is going to want to understand the potential impact (risk) to…

…the compliance lapse occurred (a.k.a. root cause). If the compliance issue impacts product already entered into commerce, the FDA is going to want to understand the potential impact (risk) to…

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Vyaire Medical

Vyaire Medical Class I Recall Affects Air Life Humidification & Heated Breathing Circuit Kits

By MedTech Intelligence Staff

Today FDA sent out an alert about Vyaire Medical recalling its AirLife Humidification Chamber and Heated Breathing Circuit Kits. The Class I recall is a result of a manufacturing error…

Today FDA sent out an alert about Vyaire Medical recalling its AirLife Humidification Chamber and Heated Breathing Circuit Kits. The Class I recall is a result of a manufacturing error…

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Gary Warren, ivWatch
Soapbox

Designing for all Stages of the Technology Adoption Lifecycle

By Gary Warren

…working in the smartphone market pre-Apple iPhone. At that time, the market was dominated by companies like Nokia, Palm and Research in Motion’s Blackberry. These companies hired the best human…

…working in the smartphone market pre-Apple iPhone. At that time, the market was dominated by companies like Nokia, Palm and Research in Motion’s Blackberry. These companies hired the best human…

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EU MDR Compliance

New EU MDR Regulations and Revamp of the Medical Device Directive

By Shilpa Gampa

…manufacturer; OBL: Own Brand Labeler) Technical File Compilation Compilation of technical file as per new EU MDR regulations (Including for the accessories/non-medical/software devices/high risk) Amendment of technical files for software…

…manufacturer; OBL: Own Brand Labeler) Technical File Compilation Compilation of technical file as per new EU MDR regulations (Including for the accessories/non-medical/software devices/high risk) Amendment of technical files for software…

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