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
  • GAP analyses
  • Supplier management, supplier qualification, auditing and preparing of quality assurance agreements
  • Preparation, execution and follow-up of audits & self-inspections
  • Validation and qualification of e.g. QM software
  • Change management and CAPAs
  • Preparation of management reviews
  • Accompanying of technology and product transfers

Data integrity (DI) and IT security

  • GAP analyses and risk assessments
  • Identification of critical electronic records
  • Data mapping
  • Establishing of data integrity infrastructures
  • Support in implementing the requirements for IT security according to ISO 27001/ BSI-Standards
  • Conducting training on data integrity and information security issues

Interim management

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