R&D poster

Research & Development

Defined media for Research & Development.

STEM ALPHA MEDIA STATUS

Quality Management System of STEM ALPHA is certified ISO 9001-2008 in compliance with ISO 13485 – 2003 of medical device since 2007.

 

Guidelines

In compliance with EC/98/79 of the Council of 27th October 1998 on in-vitro diagnostic medical devices.

 

Position of the French Health Products Agency since 1999 (AFSSAPS / ANSM) about State of STEM ALPHA products.

 

In compliance with the EC. MEDDEV. 2.14/1 rev. 1 January 2004, rev.1

 

IVD GUIDANCES: Borderline issues, A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES "Produits Frontière"

 

Recital 8 of Directive 98/79/EC states:  Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation. 

 

In compliance with the MEDDEV. 2.14/2 rev.1 February 2004, IVD GUIDANCE: Research Use Only Products (RUO).