How can we help?
- Writing the risk management process description in accordance with applicable standards and regulations
- Implementing and maintaining the risk management process
- Preparing risk management plans and reports
- Covering all risk analysis aspects (e.g., mfg processes, quality processes, design, usability, software, cybersecurity)
- Determination of benefit-risk
- Answering the risk management related questions raised by notified bodies and authorities
- Offering customized and open training for medical device risk management
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.
QAdvis and Scandinavian CRO join Aurevia to strengthen clinical research and regulatory expertise
Meet us at ESCMID 2025 in Vienna
Aurevia appoints Jonna Pelanti as the new Head of EQA business area
Meet us at BioMedica in Dublin