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.

CE - Declaration of conformity

IVDD 98/79/EG

Since 1998 AID's QM (Quality Management) complies with the European Law on Medical Devices (Medizinproduktegesetz), particularly with the in vitro diagnostic directive (IVDD) 98/79/EC (Instruction, Technical Documentation depended on product). IVDD covers the placing on the market and putting into service of in vitro diagnostic medical devices. AID GmbH developed and manufactured products meet all of the relevant essential requirements contained within the IVDD. AID GmbH products carrying the CE sign can be sold without further validation anywhere in the European Union.

Medical devices - Quality management systems - Requirements for regulatory purposes

DIN EN ISO 13485

ISO 13485 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more. AID GmbH is certified according to DIN EN ISO 13485.

ISO 13485 and 21 CFR Part 820 are harmonized.

Quality management systems - Requirements

DIN EN ISO 9001

ISO 9001 is a standard for quality management systems. It is designed to help organizations ensure that they meet customers’ needs. AID GmbH is certified according to DIN EN ISO 9001.

Risk Assessment

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices. AID GmbH is certified according to DIN EN ISO 14971 since 2003.

Medical device software - Software life cycle processes

DIN EN 62304

Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing 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.

Application of usability engineering to medical devices

IEC 62366-1

IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: 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

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

Safety requirements for portable electrical equipment, e.g. computer.

Electromagnetic Compatibility (EMC)

DIN EN 61326-2-6

Electrical equipment for measurement, control and laboratory use - EMC requirements.

Environmental Aspects

RoHS Directive 2011/65/EU - Restriction of Hazardous Substances

This Directive restricts the use of potentially hazardous substances in electro-technical and electronic equipment (limits for the permissible levels), to ensure the required level of protection for people’s health and environment.

WEEE - Waste of Electrical and Electronic Equipment directive 2012/19/EU

The WEEE Directive set collection, recycling and recovery targets for all types of electrical goods.

Instruction, Technical Documentation

AID Reader Systems technical documentation are generated during the product life cycle and refers to different documents with product related data and information such as product definition and specification, design, manufacturing, quality assurance, description of features, interfaces, service and repair of a technical product as well as its safe disposal.

For a detailed manual we refer to the User Guide inter alia.

 

GMP/GLP

GMP is as a quality standard included in the German Law on Pharmaceutical Products (Arzneimittel-gesetz). AID 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).