What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.
What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.
As India’s cancer burden grows, the Indian cancer diagnostic and treatment market offers many opportunities for Western medical device companies that make such products. To succeed, Western companies need to develop their strategies in India carefully.
As India’s cancer burden grows, the Indian cancer diagnostic and treatment market offers many opportunities for Western medical device companies that make such products. To succeed, Western companies need to develop their strategies in India carefully.
There is a pressure on medical device product development teams to come to terms with new types of users, environments, distribution and sales models as opposed to more traditional scenarios of device use and sale, says ide’s Richard Sokolov.
There is a pressure on medical device product development teams to come to terms with new types of users, environments, distribution and sales models as opposed to more traditional scenarios of device use and sale, says ide’s Richard Sokolov.
Data reporting can be a very tedious process for medical device manufacturers. The functionality of the device needs to be spot-on for it to be considered viable in the medical community. Because there is little to no room for error in this process, medical devices must help decrease error prone manufacturing activities, and in many cases also help companies meet the desired Six Sigma goal for process control.
Data reporting can be a very tedious process for medical device manufacturers. The functionality of the device needs to be spot-on for it to be considered viable in the medical community. Because there is little to no room for error in this process, medical devices must help decrease error prone manufacturing activities, and in many cases also help companies meet the desired Six Sigma goal for process control.
Solutions from the field of micro system engineering help to make faster, more flexible and smarter medical devices. The ambitious goal of the developers is to sustainably enhance the quality of patients’ lives through more mobility, faster test results on location, checking vital signs and blood values or through innovative therapy systems for the chronically ill.
Solutions from the field of micro system engineering help to make faster, more flexible and smarter medical devices. The ambitious goal of the developers is to sustainably enhance the quality of patients’ lives through more mobility, faster test results on location, checking vital signs and blood values or through innovative therapy systems for the chronically ill.
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
Quality should be considered at all stages of production, starting at the earliest stages of product design, says Dr. Vinny Sastri, President of Winovia LLC. Quality System Regulations Series Reports Sponsored by
Quality should be considered at all stages of production, starting at the earliest stages of product design, says Dr. Vinny Sastri, President of Winovia LLC. Quality System Regulations Series Reports Sponsored by
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.
A high degree of risk identification and management throughout the supply chain is what establishes a company as ‘world class,’ says Steve C de Baca – Senior VP, Global Quality & Regulatory, Beckman Coulter Diagnostics.
A high degree of risk identification and management throughout the supply chain is what establishes a company as ‘world class,’ says Steve C de Baca – Senior VP, Global Quality & Regulatory, Beckman Coulter Diagnostics.
Rx-360, an international pharmaceutical supply chain consortium, which helps its members share best practices to ensure the integrity of the healthcare supply chain, is now gearing for growth in the device space. What lessons can device makers learn?
Rx-360, an international pharmaceutical supply chain consortium, which helps its members share best practices to ensure the integrity of the healthcare supply chain, is now gearing for growth in the device space. What lessons can device makers learn?
