How can we help?
Aurevia helps manufacturers comply with the clinical evidence requirements of the IVD Regulation by:
- making the performance evaluation plan
- making plans and reports for analytical performance studies
- demonstrating the scientific validity through a systematic literature review
- making plans and reports for clinical performance studies
- making the performance evaluation report
Regulatory plans
Our experienced professionals help medical device manufacturers develop regulatory plans that support their entire product lifecycle.
Technical documentation
All medical devices must have documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and developing your 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
The international standard for the 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 national law.
IVD performance evaluation
In vitro diagnostic medical device (IVD) regulations are set in the EU In Vitro Diagnostics Regulation (IVDR).
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the most challenging cases.
Medical software
Let our experts help you understand and adhere to medical device software regulations throughout the entire lifecycle.
Risk management ISO 14971
We can help you setup and implement a risk management system and prepare risk management documentation.
Notice about a change in some of our email addresses
How do you shape regulatory complexity into strategic clarity?
Fast track for mononational clinical trial applications in Sweden
Upcoming webinar: what IVDR Article 5(5) means for your lab
