CE

Since 1998 AID's QM (Quality Management) complies with the German Law on Medical
Products (Medizinproduktegesetz). AID Products carrying the CE sign can be sold
without further validation anywhere in the EU (European Union).

GMP

GMP is as a standard included in the German law on Pharmaceutical products
(Arzneimittelgesetz) with which we comply.

DIN EN ISO 9001

Our QM System complies with the ISO 9001 since 1998 which was superseded by the
DIN EN ISO 13485, year 2000 edition.

DIN EN ISO 60601-1-4

This is the validation for Software and Hardware for medical products. This
internationally accepted norm is largely identical to FDA requirements.

21CFR Part 11

These are the specification for equipment used in clinical trials. This stresses
requirements such as data organisation, audit trail and electronic signatures.
We meet these requirements since the 3.0 AID EliSpot Software update.

All audits were carried out by the certifying organization DQS (Deutsche
Gesellschaft zur Zertifizierung von Managementsystemen mbH).