Services relating to ISO 13485 for manufacturers of
medical devices

When the focus is on the efficiency of your QM system

QM activities

  • Monitoring of QM systems according to ISO 13485
  • Self-inspections & audits
  • Preparation of management reviews
  • Validation and qualification of e.g. QM software
  • Change management and CAPAs
  • Accompanying of technology and product transfers
  • Conducting of mock audits or preparation and follow-up of audits
  • Supplier management, supplier qualification, auditing and preparing of quality assurance agreements
  • Management of nonconformities
  • Conducting gap analyses

Interim management

  • Quality management
  • Production
  • Business development
  • Marketing & sales