Ensuring the quality of medical devices

Ensuring the quality of medical devices

The 1st VDI Conference "Quality Assurance and Contamination Control of Medical Devices" on November 5 and 6, 2012 in Nuremberg discusses the entire process chain of medical devices

How clean do medical devices actually need to be? The scandals about contaminated medical devices show that consequences must follow. With the 1st VDI Conference "Quality Assurance and Contamination Control of Medical Devices" on November 5 and 6, 2012 in Nuremberg, the VDI Knowledge Forum offers a platform to discuss important influencing factors of the entire medical process chain.

At the conference, experts will present quality assurance and specification of product purity as well as purity requirements for sterile and non-sterile implants. Additionally, there will be a lecture on the use and handling of implant materials in hospitals. Furthermore, speakers will address the influences on the biocompatibility of medical devices and measurement technology for purity validation.

The second day of the conference will focus on standards and regulations such as Good Manufacturing Practice (GMP) and Medical Device Regulation (MDR), as well as the results of manufacturer surveillance of medical devices. A lecture will show how medical technology can learn from the pharmaceutical industry, focusing on inspections.

Another program item is project planning for an optimal production environment. Questions such as cleanroom versus isolator and modular cleanroom systems also play a role. Presentations on automation, such as laboratory robots for sterile production, as well as purity requirements for machines and packaging in cleanrooms, round off the program.

The special seminar "Cleanroom-Compatible Materials for Contamination-Sensitive Applications" on November 7, 2012, offers all participants the opportunity to delve deeper into cleanroom-compatible materials for contamination-sensitive applications.

Both events are aimed at experts and decision-makers, planners, as well as managers from research and development, quality assurance, and production of medical devices, as well as from the supplier industry, research institutions, and hospitals.

Registration and program at www.vdi.de/qualitaet_medizinprodukte
or via the VDI Knowledge Forum Customer Center, P.O. Box 10 11 39, 40002 Düsseldorf, Email: wissensforum@vdi.de, Phone: +49 211 6214-201, Fax: -154.