Quality management for medical devices

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.

  • Development of a quality management system for medical devices in accordance with ISO 13485 and preparation for certification
  • Updating existing quality management systems and expanding them to cover medical devices
  • Evaluation of and support in quality assurance
  • Carrying out audits and self-inspections
  • Assistance with audits performed by notified bodies

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.