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Labquality
How can we help?
Labquality 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
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Related Services
Electrical Safety IEC 60601
IEC 60601-1 is the basic safety standard for medical electrical devices and systems.
Biological Safety ISO 10993
We provide medical device manufacturers help with setting up a biological safety evaluation process and preparing biological evaluation documentation.
Risk Management ISO 14971
Labquality provides medical device manufacturers help in setting up and implementing a risk management system and preparing risk management documentation.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
Regulatory plan
Labquality can help medical device manufacturers in creating a regulatory plan.
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.
Medical software
Labquality also provides comprehensive support for medical software lifecycle.
