AID Reader Systems comply with the requirements of

“international regulatory guidelines”

Our philosophy does not allow compromises. AID GmbH not only fulfills the basic requirements under consideration of the harmonized standards.

We do more!

Based on patient safety our company wants not only the highest security but also permanently satisfied customers and first-class quality. The following document provides an overview of the commitments, standards and management systems that help us to adopt the principles implemented in our company.

IVDD 98/79/EG

Since 2006 Advanced Imaging Devices GmbH Quality Management System complies with the European Law on Medical Devices, the in vitro diagnostic directive (IVDD) 98/79/EC. IVDD covers the placing on the market and putting into service of in vitro diagnostic medical devices. Advanced Imaging Devices GmbH developed and manufactured products to meet all applicable requirements contained within the IVDD.

Medical devices - Quality management systems - Requirements for regulatory purposes

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).

Risk Assessment

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices. Since 2006 Advanced Imaging Devices GmbH has introduced and maintained a risk management system according to DIN EN ISO 14971 (ISO 14971).

Medical device software - Software life cycle processes

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.

Application of usability engineering to medical devices

DIN EN ISO (IEC) 62366-1

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

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.

Safety

DIN EN 61010-2-101

We meet the safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment to eliminate electrical hazards to operating staff.

DIN EN 62638

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

Electromagnetic Compatibility (EMC)

DIN EN 61326-2-6

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

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).