B Medical Systems S.á r.l. successfully passed the certification audit according to the harmonized European Quality Management System Standard for Medical Devices EN ISO 13485 and the European Medical Device Directive 93 / 42 / EEC.
All medical devices manufactured by B Medical Systems S.á r.l. will be labeled with the CE-Label. The product in question concerns blood product cooling devices / blood bank refrigerators. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
Our medical device products will be all blood banks refrigerators from our range BR, as well as all plasma freezers from our ranges MF and FR, as well as our contact shock freezers MFB.
Why the ISO 13485 certification?
This ISO Standard was published in 2003 and represents the requirements for a comprehensive management system for the design and manufacture
of Medical Devices.
This certificate demonstrates that an organization is able to provide Medical Devices and related services, meeting customer and regulatory requirements applicable to medical devices and related services.
The primary objective is to facilitate harmonized Medical Device regulatory requirement for quality management system.
The positive assessment to this certificate allows the CE Mark and the permission to sell the Medical Device in the European Union.