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