Leukocare Receives Certification to ISO 9001 and ISO 13485

Leukocare AG, a privately owned company that develops  biofunctional surfaces using proprietary stabilising postcoating technology, announced today that it has established a quality management system (QMS) in accordance with ISO 9001:2008 and ISO 13485:2003 standards for medical devices.

To achieve certification to the ISO standards, the company implemented a QMS for its operations to ensure consistent quality of the company’s development processes. KEMA Quality bv 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,” says 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.”

Tags: ISO 13485, ISO 9001, KEMA Quality, Leukocare, Leukocare AG