Eurofins Product Testing - Medical Devices
Eurofins offers services on medicinal products and medical devices.
For further information please contact our national organisations or our specialists.
Medical Devices
Eurofins Biolab, with more than twenty years’ experience in the field, responds to all the pharmaceutical industry’s needs. and offers a complete range of services for the development, manufacture, and quality control of medicinal products.
Eurofins Biolab is accredited by the Italian Ministry of Health as a Pharmaceutical Laboratory authorised for the control of medicinal products for human and veterinary use.
Eurofins Biolab has also been certified by the same ministry as a Test Centre in GLP to perform chemical, microbiological and toxicity tests. Compliance with GMP and GLP standards is verified by frequent inspections done by our customers as well as by the appropriate authorities.Eurofins Biolab is also authorised for use and possession of narcotic and psychotropic substances and has the facilities and safety procedures necessary for handling sensitive materials such as antitumoral substances, antibiotics, highly toxic substances, etc.
Eurofins Biolab services for the pharmaceutical sector include:
- Quality Control
- Development and Validation of Analytic Methods Stability studies
- Chemical studies Chemicophysical characterization studies
- Toxicity studies
- Microbiological studies
- Qualification of packaging
- Qualification and validation of environments, equipment and processes
- Studies for pharmacokinetics
- Development of medicinal products
- Development and Validation of Analytic Methods Stability studies
Medical devices
In force since 1993, Directive 93/42/EEC regulates the design, manufacture and marketing of Medical Devices in the European Union and stipulates their fundamental safety requirements
Eurofins Biolab’s multidisciplinary team and profound knowledge of the different types of Medical Devices and the regulations that apply to them makes it possible to offer companies in the sector a thorough service, from product development to certification.
Eurofins Biolab is a Notified Body (n°0477) authorised by the Italian Ministry of Health to certify Medical Devices that are covered by Directive 93/42/EEC.
The Vimodrone laboratories, with EN 17025 accreditation from SINAL, perform a wide range of assays to demonstrate product conformity to specifications and product type conformity to safety requirements.
Eurofins Biolab services for the Medical Devices sector include: