2013 Exhibition Programme

Metal Alloy Could Increase Visibility of Medical Implants under X-ray

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 Expands Medical Packaging Footprint in Germany and United States

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 [...]

UK MHRA Announces Tracking System for Medical Implants

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 [...]

Irish Engineering Student Helps Zimmer Reduce Production Bottlenecks

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 [...]

France Lets “Sunshine” In: What Transparency Really Means for the Medical Industry

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 [...]

Medical Device Regulations Draft: MEPs Propose more than 900 Amendments

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. [...]

Sterile Medical Manufacturing Training Coming to Sheffield, UK

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 [...]

The Tangled Destinies of Europe’s UDI, Eudamed Database and Medical Device Regulation

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 [...]

Asia’s Medtech Power Markets

From the Consultant’s Corner Newsletter, June 2013 Medical device industry observers and stakeholders have touted Asia in recent months for its strong growth potential and relatively healthy economic conditions. Three Asian markets, however, have recently shown specific signs of strength generally ascribed to the region as a whole. Taiwan’s market to approach $3 billion in [...]

Eucomed Publishes Guidance on RoHS 2 for Medical Device Manufacturers

The Eucomed Electronic Devices Working Group has published a guidance document to clarify conformity assessment requirements for manufacturers of medical devices that fall within the scope of the recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU (RoHS 2). Like the medical device directives, RoHS 2 is a CE marking [...]