Regulatory plans
Regulatory plans for medical device manufacturers.
Technical Documentation
All medical devices must have a set of documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and creating the needed Technical Documentation.
Electrical Safety IEC 60601
IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.
Biological Safety ISO 10993
International standard of biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.
IVDR compliance for in-house developed tests
Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.
IVD Performance Evaluation
In vitro diagnostic medical device (IVD) regulations are set out in the EU In Vitro Diagnostics Regulation.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
Medical software
Adhering to medical device software regulations throughout the entire lifecycle.
Risk Management ISO 14971
Setting up and implementing a risk management system and preparing risk management documentation.
Aurevia appoints Jonna Pelanti as the new Head of EQA business area
Meet us at BioMedica in Dublin
Aurevia appoints Ulrika Hammarström as the new Head of CRO business area
Introducing the EQA Pilot Studies 2025