Validation of the AID BacSpot Colony Counter

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/GLP

Advanced Imaging Devices GmbH products (AID Reader Systems) are designed to work in a GMP/GLP environment according to GMP conditions. They can be adapted to individual customer wishes at any time to meet the requirements of the severe internal and external guidelines (GMP/GLP).

 

FDA 21 CFR Part 11

Part 11 of the Code of Federal Regulations defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. The software of all AID devices can be adjusted to meet these requirements.

 

DIN EN ISO 13485 and 21CFR820

ISO 13485 is the harmonized standard for a quality management system for medical device companies. It covers for medical devices all requirements regarding process control, design control, retention of records, accountability, traceability and more. Advanced Imaging Devices GmbH is certified according to DIN EN ISO 13485. Advanced Imaging Devices GmbH’s quality system also fulfils the requirements of 21CFR820 (QSR).

 

DIN EN 62304

We offer software which is an integral part of medical devices or standalone software. Establishing the safety and effectiveness of such software requires knowledge of that the software is intended to do and demonstration that the use of the software fulfils those intentions without causing any unacceptable risks. Therefore, we follow the DIN EN ISO 62304 during the design, servicing and maintenance of our software.

 

DIN EN ISO (IEC) 62366-1

We use DIN EN ISO 62366-1 to design for high usability.

 

DIN EN 62638

We meet the safety requirements for portable electrical equipment, e.g. computer.

 

DIN EN 61326-2-6

We fulfil the requirements for electromagnetic compatibility for electrical equipment for measurement, control and laboratory use - EMC requirements.