Watch the archived free webcast "How to Achieve Compliance with IEC 62304 for Medical Device Software Development." Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development.
Syringe pumps need to be reliable and resilient in order to support automated instruments. A new syringe pump is designed to withstand harsh reagents that would damage other pumps.
Le défi pour le fabricant est de rendre cette pièce compatible avec les autres composants du dispositif, selon un procédé industriellement et économiquement efficace.
Le site français de Zimmer Manufacturing (Etupes, Doubs) a mis au point un nouveau processus de traitement de surface pour les prothèses de hanches. Ce process consiste en l’application de couches de titane et d’hydroxylapatite au moyen d’un système de traiteme...
EMDT's series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here we talk to Alistair Taylor, former CEO of Biocompatibles plc and current chairman of Nightingale-EOS Ltd, among other companies.
There is a European Patent Office, but, as I am sure you are painfully aware, there is no single European patent. Instead, as noted recently in the Financial Times, there is simply a “basket of national p...
In vitro diagnostic medical devices are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part article discusses European requirements related to performance evaluation studies. Part 2 will di...
As European and US markets reach saturation, medical device manufacturers increasingly look to emerging markets as engines of growth. An in-country ER&D partner can provide invaluable help mapping what is bound to be unfamiliar terrain.
In addition to helpful techniques that simplify surge testing, this article includes easy-to-implement procedures to ensure that the defibrillation-proof surge tester is working correctly in-between calibration cycles.
En se dotant d’une double implantation géographique (Besançon les années impaires, Lyon les années paires), MEDTEC France élargit sa zone d’influence et renforce son attractivité. Objectif : accroitre les opportunités de contacts qua...
Micropumps can be an attractive alternative to standard pumps because of their size, weight and low energy demand. This article describes one micropump, in particular, which offers the possibility of intrinsic flow control, thereby fulfilling requirements for safety and accuracy under varying condit...
Innover ou mourir : jamais cette expression n’a sonné aussi juste. Et ce n’est pas pure vue de l’esprit que de formuler un tel dilemme à propos des mécanismes de protectio...
This year’s Medical Design Excellence Awards saw a strong showing from international entrants. Manufacturers in China and India, in particular, are finding novel ways to cut costs without affecting quality.
In December 2010, two new European guidelines on medical device clinical studies were published. One covers serious adverse event (SAE) reporting while the other provides guidance on when clinical investigations should be conducted, together with general principles to be observed when conducting suc...
The Formal Objection of the European Commission to 11 medical device standards has caused a certain amount of consternation and even alarm. The initiative has the potential to seriously undermine the EU regulat...
A team of researchers from the University of Trento (Trento, Italy) has been working with IBM to advance the state of the art in teaching computers to conversationally interact with humans. The Trento group is led by Professor Giuseppe Riccardi and Professor Alessandro Moschitti. Their work furthers...
Complex surgical interventions can be performed faster with fewer postoperative complications when surgeons use state-of-the-art navigation technology. Uptake has been limited, however, because of mechanical limitations and cost. New RFID-based navigation systems address those issues.
Medizingeräte werden immer komplizierter; jetzt sind softwaregesteuerte Anwendungen ein integraler Bestandteil von ihnen, deren Ausfall zu Todesfällen oder schweren Personenschäden führen könnte. Trotz dieser erhöhten Komplexität reflektieren die Normen für me...
This white paper, "The Benefits of Using Rigorously Tested Routines from Numerical Libraries—Medical Device Edition", speaks to the difficulties medical device manufacturers often have in ensuring that code is correct, debugging is properly done, and documentation is available for so...
Syringe pumps need to be reliable and resilient in order to support automated instruments. A new syringe pump is designed to withstand harsh reagents that would damage other pumps.
Le défi pour le fabricant est de rendre cette pièce compatible avec les autres composants du dispositif, selon un procédé industriellement et économiquement efficace.
Le site français de Zimmer Manufacturing (Etupes, Doubs) a mis au point un nouveau processus de traitement de surface pour les prothèses de hanches. Ce process consiste en l’application de couches de titane et d’hydroxylapatite au moyen d’un système de traiteme...
EMDT's series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here we talk to Alistair Taylor, former CEO of Biocompatibles plc and current chairman of Nightingale-EOS Ltd, among other companies.
There is a European Patent Office, but, as I am sure you are painfully aware, there is no single European patent. Instead, as noted recently in the Financial Times, there is simply a “basket of national p...
In vitro diagnostic medical devices are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part article discusses European requirements related to performance evaluation studies. Part 2 will di...
As European and US markets reach saturation, medical device manufacturers increasingly look to emerging markets as engines of growth. An in-country ER&D partner can provide invaluable help mapping what is bound to be unfamiliar terrain.
In addition to helpful techniques that simplify surge testing, this article includes easy-to-implement procedures to ensure that the defibrillation-proof surge tester is working correctly in-between calibration cycles.
En se dotant d’une double implantation géographique (Besançon les années impaires, Lyon les années paires), MEDTEC France élargit sa zone d’influence et renforce son attractivité. Objectif : accroitre les opportunités de contacts qua...
Micropumps can be an attractive alternative to standard pumps because of their size, weight and low energy demand. This article describes one micropump, in particular, which offers the possibility of intrinsic flow control, thereby fulfilling requirements for safety and accuracy under varying condit...
Innover ou mourir : jamais cette expression n’a sonné aussi juste. Et ce n’est pas pure vue de l’esprit que de formuler un tel dilemme à propos des mécanismes de protectio...
This year’s Medical Design Excellence Awards saw a strong showing from international entrants. Manufacturers in China and India, in particular, are finding novel ways to cut costs without affecting quality.
In December 2010, two new European guidelines on medical device clinical studies were published. One covers serious adverse event (SAE) reporting while the other provides guidance on when clinical investigations should be conducted, together with general principles to be observed when conducting suc...
The Formal Objection of the European Commission to 11 medical device standards has caused a certain amount of consternation and even alarm. The initiative has the potential to seriously undermine the EU regulat...
A team of researchers from the University of Trento (Trento, Italy) has been working with IBM to advance the state of the art in teaching computers to conversationally interact with humans. The Trento group is led by Professor Giuseppe Riccardi and Professor Alessandro Moschitti. Their work furthers...
Complex surgical interventions can be performed faster with fewer postoperative complications when surgeons use state-of-the-art navigation technology. Uptake has been limited, however, because of mechanical limitations and cost. New RFID-based navigation systems address those issues.
Medizingeräte werden immer komplizierter; jetzt sind softwaregesteuerte Anwendungen ein integraler Bestandteil von ihnen, deren Ausfall zu Todesfällen oder schweren Personenschäden führen könnte. Trotz dieser erhöhten Komplexität reflektieren die Normen für me...
This white paper, "The Benefits of Using Rigorously Tested Routines from Numerical Libraries—Medical Device Edition", speaks to the difficulties medical device manufacturers often have in ensuring that code is correct, debugging is properly done, and documentation is available for so...
Syringe pumps need to be reliable and resilient in order to support automated instruments. A new syringe pump is designed to withstand harsh reagents that would damage other pumps.
Le défi pour le fabricant est de rendre cette pièce compatible avec les autres composants du dispositif, selon un procédé industriellement et économiquement efficace.
Le site français de Zimmer Manufacturing (Etupes, Doubs) a mis au point un nouveau processus de traitement de surface pour les prothèses de hanches. Ce process consiste en l’application de couches de titane et d’hydroxylapatite au moyen d’un système de traiteme...
EMDT's series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here we talk to Alistair Taylor, former CEO of Biocompatibles plc and current chairman of Nightingale-EOS Ltd, among other companies.
There is a European Patent Office, but, as I am sure you are painfully aware, there is no single European patent. Instead, as noted recently in the Financial Times, there is simply a “basket of national p...
In vitro diagnostic medical devices are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part article discusses European requirements related to performance evaluation studies. Part 2 will di...
As European and US markets reach saturation, medical device manufacturers increasingly look to emerging markets as engines of growth. An in-country ER&D partner can provide invaluable help mapping what is bound to be unfamiliar terrain.
In addition to helpful techniques that simplify surge testing, this article includes easy-to-implement procedures to ensure that the defibrillation-proof surge tester is working correctly in-between calibration cycles.
En se dotant d’une double implantation géographique (Besançon les années impaires, Lyon les années paires), MEDTEC France élargit sa zone d’influence et renforce son attractivité. Objectif : accroitre les opportunités de contacts qua...
Micropumps can be an attractive alternative to standard pumps because of their size, weight and low energy demand. This article describes one micropump, in particular, which offers the possibility of intrinsic flow control, thereby fulfilling requirements for safety and accuracy under varying condit...
Innover ou mourir : jamais cette expression n’a sonné aussi juste. Et ce n’est pas pure vue de l’esprit que de formuler un tel dilemme à propos des mécanismes de protectio...
This year’s Medical Design Excellence Awards saw a strong showing from international entrants. Manufacturers in China and India, in particular, are finding novel ways to cut costs without affecting quality.
In December 2010, two new European guidelines on medical device clinical studies were published. One covers serious adverse event (SAE) reporting while the other provides guidance on when clinical investigations should be conducted, together with general principles to be observed when conducting suc...
The Formal Objection of the European Commission to 11 medical device standards has caused a certain amount of consternation and even alarm. The initiative has the potential to seriously undermine the EU regulat...
A team of researchers from the University of Trento (Trento, Italy) has been working with IBM to advance the state of the art in teaching computers to conversationally interact with humans. The Trento group is led by Professor Giuseppe Riccardi and Professor Alessandro Moschitti. Their work furthers...
Complex surgical interventions can be performed faster with fewer postoperative complications when surgeons use state-of-the-art navigation technology. Uptake has been limited, however, because of mechanical limitations and cost. New RFID-based navigation systems address those issues.
Medizingeräte werden immer komplizierter; jetzt sind softwaregesteuerte Anwendungen ein integraler Bestandteil von ihnen, deren Ausfall zu Todesfällen oder schweren Personenschäden führen könnte. Trotz dieser erhöhten Komplexität reflektieren die Normen für me...
This white paper, "The Benefits of Using Rigorously Tested Routines from Numerical Libraries—Medical Device Edition", speaks to the difficulties medical device manufacturers often have in ensuring that code is correct, debugging is properly done, and documentation is available for so...
The mechanical properties of a newly developed high-heat polycarbonate copolymer resin were evaluated after multiple autoclave cycles at both 120° and 134°C. Compared with conventional and other high-heat PC materials, the new resins demonstrated better impact property retention at lower...