QUALITY SYSTEM

STEM ALPHA is certified ISO 13485 : 2003 and NF EN ISO 13485 : 2012 for medical device.


 

Notified body :


BSI British Stndards Institution for ISO 13485 : 2003 and NF EN ISO 13485 : 2012

 

QAS International / IMSM (Intenational Magagement Systems Marketing Ltd) - EFQM (European Foundation for Quality Management) for ISO 9001 : 2008

About STEM ALPHA

Founded in 1998, located in France Rhone-Alpes Region's, STEM ALPHA performed its researches to obtain Animal and Human Protein-free media.

 

The traceability is ensured by a rigorous choice of raw materials answering the monographs of the pharmacopeia.

 

We design, manufacture, our products regarding cGMP-annex 1 in compliance with 2001/83/EC from medicinal product.

 

The first application is the Corneal Preservation. STEM ALPHA obtained in 2007 three marketing authorizations delivered by the French authorities of health.

 

Numerous applications, the haematology, the ophthalmology, the dermatology, the hepatology, etc... are concerned by the development of the cell and tissues therapies.

 

Our products enable significant reduction in the levels of apoptosis and necrosis, in comparison to traditional preservation media formulations.

 

A variety of cells, tissues, preserved or frozen with our Animal Component Free Media have demonstrated greatly extended shelf life and improved post-preservation cell yield, viability, and functional return.

 

This improved efficacy is made possible in the future to develop, in fully defined, serum-free and protein-free an Advanced Therapeutic Medicinal Product for biotherapy applications.

 

Quality Management System : ISO 9001 : 2008 ; EN ISO 13845 : 2012 and ISO 13485 : 2003.

ISO 13485 BSI

ISO 13485 STEM ALPHA

Certificate

Research & development

Research & development

Location

STEM ALPHA is located in Saint-Genis l’Argentière, Rhône-Alpes, France.

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Address

LA CHENEVATIERE RD389
69610 SAINT GENIS L ARGENTIERE
FRANCE
 
Tel: 33.4.74.26.30.34
Fax: 33.4.74.70.63.68