Biolife Medical Pvt. Ltd. has established comprehensive Quality Management Systems that integrate compliance with the Indian FDA and applicable international standards (ISO 13485, Medical Device Directive) & follow below quality features.
BLM ’s Quality Systems are specifically intended for the design and development, manufacture, and supply of Blood Bags.
Copies of these certificates can be obtained on request once samples are requested.
ISO 13485 is a recognized standard prescribing quality assurance management for the manufacture of medical devices. ISO 13485 presents a basic model for quality assurance covering design and development controls, manufacturing, installation, and servicing. Certification of compliance to the Medical Device Directive is required to allow the manufacturer to create the Declaration of Conformity and to affix the CE mark with the notified body number to their product labeling.
BLM has established Quality Systems that incorporate the elements of these standards. Some fundamental principles of the BLM Quality Systems include the following: