Quality first, everything else second.
Hemoteq´s QMS is the heart and central pillar of all business activities in contract development and contact manufacturing.
We ensure highest product and service quality by following a Total Quality Management philosophy and implementing risk-based approaches across all CDMO activities.
A triad of consistent QM, QA and QC principles and procedures ensures a zero defect production flow which provides the foundation for operational excellence, highest customer satisfaction and patient well-being.
The scope of our certificates [ISO 13485: 2016] covers the design, development, production and distribution of medical coatings and device drug combination products, including roles and responsibilities as legal manufacturer of combination products.
QMS audits at all levels ensure conformity with applicable laws and regulations in the global markets serviced by our clients. Hemoteq provides comprehensive customer support relative to second and third party audits.