|"La diversité des intervenants, l'intérêt des questions et des intervenants lors des débats."
Responsable validations, Tornier
|"L'aspect convivial et la possibilité d'échange facile avec les intervenants/conférenciers."
Chef de projet R&D, B.Braun Médical SAS
|"La qualité des intervenants et le niveau des informations afin de dégager une tendance la plus adéquate possible avec les enjeux en cours et à venir, et afin que les industriels puissent se préparer au mieux à ces évolutions."
Directeur Recherche Clinique, Tornier
|"Des sujets d'actualités règlementaires, des intervenants directement impliqués dans les changements à venir et permettant de disposer des différenst points de vue et attentes respectives."
Directeur Qualité et Affaires Règlementaires, Zimmer Spine
|"La journée sur la refonte de la Directives était très intéressante et les commentaires très pertinents."
Responsable Clinique, Cereplas
Two companies based in Galway, Ireland’s medtech hub, are contributing their expertise to a pan-European project designed to develop new technologies for medical manufacturing, reports www.siliconrepublic.com. Crospon, founded in 2006 to develop minimally invasive surgical devices, and Adama Innovations, which was spun out from Irish nanoscience institute CRANN earlier this year, have been selected to [...]
Ethylene Oxide Sterilisation Course Offers Participants Opportunity to Discuss Products Confidentially- Tue, 18 Jun 2013 07:54:48 +0000
An interactive course offered by High Edge Consulting will provide a detailed insight into ethylene oxide sterilisation. The course will be offered on 25 June and 15 October 2013 at Holiday Inn in Birmingham, UK. The course will cover practical aspects of the process and the detailed regulatory requirements necessary to achieve compliance to [...]
A new metal alloy could help medical implants become more visible under X-rays. The material was developed by researchers from the Materials and Surface Science Institute (MSSI) at the University of Limerick. Many implantable medical devices are made with materials that don’t show up well when using medical imaging. This can cause problems during minimally [...]
Puracon GmbH is expanding production capacity at its home base in Germany and plans to build a facility in the United States. The new facility at the company’s Rosenheim, Germany, location will have a 6000-sq-m production area, tripling its current footprint. As part of the construction project, Puracon has commissioned a second cleanroom. The new [...]
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is piloting a new tracking system for high-risk medical devices. The tracking system will start in four NHS trusts and will incorporate unique device identifiers (UDIs) into patient electronic records and national Hospital Episode Statistics databases, and analysis by the Clinical Practice Research Datalink. The system [...]
Zimmer Orthopaedics is eliminating production bottlenecks at its facility in Shannon, Ireland, and it has an engineering student to thank. Patrick Byrnes, who is enrolled at Cork Institute of Technology, analysed where bottlenecks occurred in Zimmer’s existing manufacturing processes as part of a competition organised by Ireland’s professional engineering body. Engineers Ireland awarded Byrnes the [...]
As reported in medtechinsider on 31 May 2013, France has implemented the remaining sunshine regulations. The regulations are an extension of the Bertrand law, which was passed in 2011, requiring all healthcare-related enterprises to exercise greater transparency in their relations with customers. In this article, René Clément, co-chair of Medimark Europe, which serves as an [...]
The new medical device regulations might change significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt. This became clear as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added their amendments to the regulations last month. [...]
Medical device consulting, auditing and training organisation NSF-DBA has announced an educational programme devoted to the manufacture of sterile medical devices that will be held in Sheffield, UK. The four-module course will address cleanroom and sterile medical manufacturing issues, packaging processes and the validation of cleaning processes from 15 to 19 July at the AMP [...]
From the Consultant’s Corner Newsletter, June 2013 The European Commission published its recommendation for a common framework for a unique device identification (UDI) system for medical devices in April 2013. The announced primary objective of recommendation 2013/172/EU is to improve patient safety by facilitating vigilance, market surveillance and transparency through heightened traceability of medical devices [...]