Diapharm assists clients by establishing a quality management (QM) system for medical devices (ISO 13485) and by monitoring existing ones. We help companies prepare for audits and inspections, adapt to changing requirements, check manufacturing processes (compliance check) and much more.
Diapharm ensures that clients have a quality management system for medical devices that fits their needs. Our consultants develop QM manuals and standard operating procedures (SOPs) to make sure that standardised processes reflect a company’s individual workflows. This is not a contradiction in terms; it is exactly what companies need – and it is efficient.
Did you know? In addition to consulting on quality management, Diapharm also assumes duties and responsibilities in your QM system by acting as the quality management or safety officer, for example.