.jpg)
Labquality
How can we help?
Planning the biological safety evaluation process together with the manufacturer in accordance with applicable standards and regulations- Helping the manufacturer to implement and maintain the biological safety evaluation process
- Preparing biological safety evaluation plans and reports
- Helping the manufacturer with risk analysis covering biological safety aspects
- Evaluating existing data on biological safety and helping the manufacturer in choosing the correct test pattern based on the data
- Helping the manufacturer with risk analysis covering biological safety aspects
- Contacting test facilities and arranging chemical and biological testing
- Helping the manufacturer in the interpretation of the test results
- Offering toxicological expertise through our co-operation network
- Helping the manufacturer in answering the biological safety related questions raised by notified bodies and authorities
- Offering customized training for biological safety evaluation
Contact us for more information
Leave a contact request
Related Services
Electrical Safety IEC 60601
IEC 60601-1 is the basic safety standard for medical electrical devices and systems.
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.
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.
