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Medical devices
With Whitelab Laboratories, you can ensure the effectiveness and safety of your Medical Devices thanks to a comprehensive consultancy and testing service accompanying you from the concept stage to the marketing and throughout the whole lifetime of the product.
The regulatory support includes the drafting of the Technical Files, the Risk Analysis, the process to obtain the CE marking and, in general, the guarantee that the products are in compliance with applicable regulations thanks to accredited testing protocols in line with European and international guidelines.
Whitelab's comprehensive offer also includes the evaluation of controlled environments in line with ISO 14644 and ISO 14698 standards and the environmental monitoring in the hospital sector in line with ISPESL guidelines.
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Medical Devices
Testing and services offered by Whitelab for Medical Devices.
Controlled environments
Whitelab's offer for Controlled Environments and the Hospital Sector.
Consultancy for Medical Devices
Whitelab's consultancy and regulatory support services for Medical Devices.
EMC, electrical safety and radio testing
Electromagnetic compatibility, electrical safety and radio-wireless testing.
Biocompatibility
Whitelab's offer for the biological evaluation of your Medical Device with biocompatibility studies.
Pharmaceutical packaging
Testing and services to test the pharmaceutical packaging effectiveness to ensure the maintenance of sterility.
Would you like to receive more information or schedule a customised consultation for your company? Please, fill out the form and we will get back to you as soon as possible.
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