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Labquality
How can we help?
We offer the following services to clinical laboratories:
Regulatory expert support for the planning and creation of the necessary processes and documentation.- QMS and technical documentation updates
- Support in CE marking activities
- Training and workshops on the effects of the IVDR on in-house developed tests.
- The digital Entries tool for defining the applicable requirements of the IVDR for the laboratory professionals in a matter of minutes.
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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.
IVD Performance Evaluation
Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation.
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.
For Startups, Incubators and Institutions
Regulatory compliance is a struggle for Health Tech innovators and startups where ever you go.
EU MDR and IVDR
Labquality provides medical device manufacturers help with understanding the changing regulations that set the standards of quality and safety of medical devices.
Medical software
Labquality also provides comprehensive support for medical software lifecycle.
