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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.
Regulatory plan
Labquality can help medical device manufacturers in creating a regulatory plan.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
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.
