Certification

Macopharma is an approved pharmaceutical laboratory that applies Good Manufacturing Practices (GMP) and operates using a complete Quality Assurance system certified to ISO 9001 (link to document from Bloodsafety).

All of our medical devices feature the CE marking and meet the fundamental requirements of European directive 93/42/EEC.

Some of our blood filtration systems are approved by the United States Food and Drug Administration (FDA).

CE Certificates

The THERAFLEX MB-Plasma is registered in Europe as a Class III medical device and is certified by the LNE/G-Med.

ISO Certificates

The THERAFLEX MB-Plasma is produced to the ISO 13485:2003 qualité standard as certified by LNE/G-Med. The French production site in Tourcoing has received in 2012 the ISO 14001.

Contact us

Macopharma Tourcoing

200 Chaussée Fernand Forest
59200 Tourcoing - FRANCE
Tel : +33 (0) 3 20 11 84 00
Fax : +33 (0) 3 20 11 84 03

Pharmacovigilance France

Tel : +33 (0) 3 20 11 84 00
24 days / 24 - 7 days / 7

Matériovigilance Dpt

Tel : +33 (0) 3 20 11 84 00
Tel : +33 (0) 6 63 30 55 65

To consult the complete contacts list, please click here