LEUKOCARE has been granted both ISO 9001 and ISO 13485 certification
LEUKOCARE AG, a privately-owned company developing innovative biofunctional surfaces using its proprietary stabilizing postcoating technology, announced that it has successfully established a Quality Management System (QMS) in accordance with ISO 9001:2008 and ISO 13485:2003 standards for medical devices.
In order to achieve ISO standards, LEUKOCARE implemented a QMS for its operations to ensure consistent and high quality of the company’s development processes. KEMA Quality B.V. audited LEUKOCARE for the design, development, manufacturing and distribution of technologies and products for biofunctional surface engineering and stabilisation of biomolecules in the field of medical devices, diagnostics, research products and biopharmaceuticals.
“By achieving ISO certification, LEUKOCARE can now offer full quality assurance in terms of development and implementation of our postcoating technology”, stated Michael Scholl, CEO of LEUKOCARE. “We are developing our technology for additional product ranges and this requires us to operate only on the highest standards of international quality.”
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