Presentation of the EFSPI-SlG on medical devices

 

Medical Devices

Medical devices are defined as any healthcare products that do not achieve their principal intended purpose by chemical action or by being metabolized. This definition encompasses products that vary greatly in their complexity, purpose and mode of action. It includes simple crutches as well as complex diagnosis devices such as endoscopy capsules. From a regulatory point of view, the development of medical devices is different from that of drugs, e.g. the market authorization for devices is delivered by country Notified Bodies through the CE mark, while it is delivered by the EMA in the case of drug products through the ICH guidelines

SIG

All the specificities related to the medical device industry led to the launch of a working group in the SFdS "Biopharmacie et Santé" special group. The working group was then, upgraded as EFSPI Special Interest Group (SIG) in 2010.

The purpose of the SIG on Medical Device is to provide a discussion platform for statisticians working in the Medical Device industry and to address specific needs in this field. The main aims of the group are the following:

  • To create visibility on biostatistics activities for medical devices,
  • To strengthen methodological aspects in the development of medical devices,
  • To create an expert group identified by authorities,
  • To share Good Statistical Practice.

The Medical Device group is working through monthly teleconferences of an hour:

Odd month: every 3rd Thursday 17:00-18:00

Even month: on demand and according to a doodle survey

These meetings are opportunities to share experience/concerns between statisticians from companies or independent consultants throughout Europe working in different therapeutic area.

For further information on the Medical Device SIG or to join the mailing list please contact
roland.marion-gallois@medtronic.com or register to the LinkedIn interest group: Medical Device Industry Statisticians.

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