European Medical Device Technology, October 2010, Volume 1, No. 8, Volume 1


October 13th, 2010


This Issue's Articles

US FDA is considering introducing some bold changes to the 510(k) review process. A new report describes these considerations, including the possible creation of a new Class IIb device subset.

Wireless medical devices offer increased patient comfort and unprecedented monitoring possibilities. But first, it’s important to optimise power consumption.

The road to compliance for medtech manufacturers begins with a robust quality system. This article details QSR milestones and includes a roadmap to help reach that destination.

Field service engineers who check the electrical safety of medical devices appreciate the kit’s convenience.

Implantable fibres allied with specialised textile engineering techniques enable the creation of biomedical structures that are uniquely adapted to orthopaedic applications.

An error in pump selection for a medical device can lead to manufacturing problems, device failures and reputation-damaging product returns. Here are some of the most important parameters to take into account when choosing a pump.

Researchers at Germany’s Fraunhofer Institute have optimised the surface structures of implants to promote cell adhesion and developed materials for bone tissue engineering.

Public bodies, medical device companies, suppliers and academia collaborate in the development of advanced manufacturing techniques.

Expanding the collaboration between device makers and contract manufacturers can help shorten a new device’s time to market whilst optimising cost, quality and compliance.

Field service engineers who check the electrical safety of medical devices appreciate the kit’s convenience.

EMDT’s series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Michael Scholl.