medical device Articles
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Risk information in prescription drug & medical device ads, promotional labeling – What the FDA expects
Abstract: The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices. This article gives an overview and summary of the ...
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Why PTFE Tubing is the Tubing of Choice for Many Medical Device Manufacturers
Medical device manufacturers are constantly looking to improve their device designs to increase their performance levels. There are a number of different trends in the medical device industry that manufacturers will have to consider when bringing a product to market. One of the most common trends in the medical device industry is to connect metals and plastic. Another is to enable “real ...
By Fluorostore
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Back Down Under and Racing Ahead
It has been a while since I updated this blog! Things have been extremely busy and time has flown by. So here's a very quick summary. We are delighted that Tri has continued with Cenofex Innovations as the Head of Business and Finance. We appreciate all the experience he brings to the team, and his personality and attitude are a great fit for Cenofex. We wrapped up our NSW Health-Rosenman ...
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SmartFreezer®: Meeting the Medical Device Directive for Safe Sample Management
Medical devices are an essential component of healthcare, and they have significantly improved the quality of life for many patients worldwide. These devices may be categorised by their intended use and range from simple non-invasive items to fully implantable devices. The Medical Device Directive 93/42/EEC (MDD) is a regulation that sets out the essential requirements that medical devices must ...
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Parts Cleanliness Testing for the Medical Device Industry
Abstract In the medical device industry it is becoming increasingly critical to ensure that parts are clean. Infections or rejections due to inadequate or improper cleaning can result in serious health problems, major litigation, and, in some cases, business failure. While a rigorous cleaning method is important, it is also necessary to quantify that the cleaning method was effective. That is, ...
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Tepha - case study
Tepha Inc. is a medical device firm that develops and commercializes innovative products based on the company’s proprietary PHA (polyhydroxyalkanoate) bioaterial technology. Tepha began working with POS in 2002 to develop its biopolymer resin production processes. These novel process had not yet been demonstrated at the pilot plant scale when the company started working with POS. Today, ...
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QMS Expert vs QMS Expert...alias - Today Everybody is an Internet Certified QMS Expert
The newbie QMS Managers Conundrum – 5 things to identify the right Expert? As a newly minted QMS manager in a medical device startup, I turned to the internet for what to do. Soon I had to realize that today everybody is an internet certified QMS expert. There was information galore, in fact so much information that trying to figure out what to even look at became the main problem. This ...
By qmsWrapper
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The Netherlands Publishes Report on Nanotechnologies in Medical Devices
The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices. RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years. According to the report, ...
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AngioDynamics and Cardiva Expand Partnership to Bring Life-Saving Products to More Patients in Europe
We are pleased to announce an expanded partnership with Cardiva, a Spanish-based medical device company. The partnership builds on an existing collaboration between AngioDynamics and Cardiva, which has seen the successful distribution of AngioDynamics’ vascular access portfolio in Spain and Portugal since 2012. The expanded partnership will now include AngioDynamics’ oncology ...
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Fluoropolymers Market Growing in Wake of Covid-19 Pandemic
According to reports in 2019, the fluoropolymer coatings market was scheduled to enjoy steady growth over the next five years. However, Covid-19 has caused a need to adjust the numbers. The industry is seeing rapid growth due to Covid-19 because medical device manufacturers are having to produce more products at a faster rate. The dielectric properties of fluoropolymers as well as the lubricity ...
By Fluorostore
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The Top 5 medtech news stories of 2021
The lingering COVID-19 pandemic was top of mind in 2021, but there was much more going on in the medical device industry. The Life Sciences editorial team here at WTWH Media discussed their top picks during the December 17 episode of our DeviceTalks Weekly podcast. Read Entire Article on Medical Design & Outsourcing ...
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Diversity is a key component of success for the medical device industry
Ensuring your voice is heard “I think as an organisation we are quite diverse and reasonably good at making sure that everyone gets their voice heard articularly the junior staff who are always encouraged to make their suggestions,” she says. “Engineering is ultimately problem solving, so the more different kind of attitudes and opinions you can get to a problem, the more ...
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Humidity’s Impact on Medical Devices
When hearing terms like humidity and relative humidity, people often think about the weather. This is because water vapor has an impact on how humans perceive comfort; both high humidity and low humidity can make people feel uncomfortable. You might already be aware that amount of water vapor present in air can impact how a medical device performs. Understanding how water vapor affects analysis ...
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Garwood Medical Devices, LLC would like to thank and honor all those who have served on this Veteran’s Day
Veteran’s Day is very special to Garwood Medical as our company is named to honor two veterans and our principal firmware engineer has served as well. We would like to honor and thank all veterans who have served our country. As we continue our work on BioPrax™, we continue our work to help veterans who suffer from implant infections. The namesakes of Garwood include our ...
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The Importance of Quality Management in the Medical Device Industry
As the world struggles to come up with a treatment for the COVID-19 virus, it’s important to remember all the amazing innovations taking place in the medical device and life sciences world: Implantable devices, like one that measures things like elevated filling pressure and weakened ventricular contraction, enabling physicians to detect risk of heart failure weeks in ...
By EtQ, LLC
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How Proper Packaging Improves the Shelf Life of Medical Devices
Medical devices are incredibly important in today’s world. They play a significant role in the treatment and prevention of various medical conditions. However, their effectiveness can be compromised if they are not packaged correctly. Packaging is an essential component of maintaining the integrity and shelf life of medical devices, especially during transportation and storage. Read on ...
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20 medical device startups you need to know
Imperative CareCampbell, Calif.Founded: 2015Technology for stroke treatment Imperative Care‘s TracStar LDP, touted as the first LDP on the market, is a 0.088 in. large bore access catheter designed to get closer to the treatment site for stroke procedures, while its Zoom aspiration portfolio, designed to work with LDP, delivers trackable aspiration catheters that are optimized for fast, ...
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Medical Device Regulation - Indian Perspective
The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed ...
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BEAT Continuous non-invasive Lactate Monitoring In Critical Care and Monitoring Disease Progression in Covid-19
Nemaura’s CLM (Continuous Lactate Monitoring) device is based on the BEAT™ platform used in sugarBEAT®, with appropriate adaptations to the sensor chemistry, the algorithm and the mobile app interface. Nemaura is evaluating the timelines for bringing this product to market as a Class 2 approved medical device. ...
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Matrix LIMS at a medical device manufacturer case study
Organisation Boston Scientific is a major medical device manufacturer that specializes in minimally invasive devices, such as catheters and such. They have over 25,000 employees in 14 plants around the world and spend over $1B dollars annually on R&D. The Sterilization Technical Services group based in Maple Grove, MN supports new product development for sites that are using ethylene oxide ...
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