MEDICAL DEVICES - LABORATORY/CLINICAL TESTING & REGULATORY ASSISTANCE

Coordination and monitoring of CLINICAL INVESTIGATIONS on medical devices of various classes of risk, in compliance with UNI EN ISO 14155 and ICH-GCP guidelines.
Support for the stipulation of insurance policies.

Bio Basic Europe supports its client at every stage of its product life cycle, ensuring compliance with all mandatory legal and regulatory requirements.

IN VITRO, CHEMICAL-PHYSICAL, MICROBIOLOGICAL ANALYSIS 

SAFETY AND EFFICACY DERMO-CLINICAL EVALUATIONS 

REGULATORY AND TECHNICAL SCIENTIFIC CONSULTANCY SERVICES 

Sectors:

Cosmetic Products ° Food supplements ° Medical devices ° Medical surgical devices (PMC) ° Biocidal products ° Hazardous mixtures ° Detergents

Why Bio Basic Europe is your ideal partner: 

♕ Experienced and qualified internal staff;
♕ Customized design of each studio according to customer needs;
♕ Technical-scientific collaboration with national and international University Institutes, Foundations, Hospitals / Medical Studies and specialized physicians;
♕ Support of the National Authorities in the health field and Certified Bodies; 
♕ High investments in training and scientific research.