Validation of the AID BacSpot Colonies Counter
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 is as a standard included in the German law on Pharmaceutical products (Arzneimittelgesetz) with which we comply.
DIN EN ISO 9001
Since 1998 our QM System complies with ISO 9001, which was superseded by DIN EN ISO 13485, year 2000 edition.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 electronic records, detailing data organisation, audit trail and electronic signatures.
All audits were carried out by the certifying organization DQS (Deutsche Gesellschaft zur Zertifizierung von Managementsystemen mbH).