Quality

All operations within EMCM are under the purview of an effective Quality Management System, the primary mandate of which is to control and to assure that only high quality and safe products will leave EMCM and thus enter the market and that compliance with the applicable regulations is maintained.

To this effect, EMCM is an ISO 9001:2008, EN ISO 13485:2012 and EATB certified company which acknowledges the compliance maintained in business practices as well as manufacture of Medical Devices. EMCM is a GMP Licence institution, processing a broad range of healthcare products for the pharmaceutical, medical devices and tissue market sections in the healthcare industry. In credence to its quality compliance, EMCM has been successfully inspected by the USFDA, ANVISA and other European authorities for providing products to the global markets. 

Training programs are established and maintained on all levels of the organisation and include basic GMP, various function specific training depending on activities and position within the organisation.

According to standard procedures, EMCM performs validation and/or verification of processes, qualification of equipment, utilities and analytical methods. All critical processes for manufacturing Biomaterials and Pharmaceuticals are validated. A Master Validation Plan describes the requirements and structure, including responsibilities for the execution of validation and qualification. Equipment qualification follows the IQ/OQ/PQ qualifications, according to planning. Routine maintenance and calibration are structurally planned and executed.

EMCM has been granted Tissue Licence (in Dutch) according to the European Directive 2004/23 as a Tissue Establishment by the Ministry of Health in The Netherlands. This implies that tissue products processed by EMCM are sterile and fulfil all the quality requirements mentioned in the European Directives for quality and safety of tissues and cells.

All human tissue donors are serologically tested for blood and tissue transmissible infectious diseases. These tests are performed and released by a certified laboratory. Human tissue processed at EMCM is derived from donors who fulfil all the requirements of the European Directives for quality and safety of human tissues and cells (2004/23EU 2006/86EU and 2006/17EU) which includes negative test results covering Hepatitis B/C, Lues, HIV, amongst others. We would be happy to share with you our Serology criteria upon request.

Bovine tissue is sourced from closed herds in Australia/New Zealand against a stringent incoming materials inspection, whilst porcine material is tested against transmissible viruses and diseases. The production of human and animal based products are clearly separated within the complex & business, ensuring no cross contamination occurs and is in full compliance with the European and International regulatory guidelines.

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