Quality Management & Regulatory Affairs
We help our customers to fuel business growth through clever QM & RA strategy focused on EU and USA markets.
Regulatory Affairs
- Regulatory requirements and regulatory approval strategies
- Product approvals (active / non-active medical devices)
- Technical documentation
- Change management
- Recertification
Quality Management
- Quality management system certification (i.e. ISO 13485 / ISO 9001 / MDR / CFR Part 820 / MDSAP)
- „Audit Readiness“ and support during external audits
- Internal audits and supplier audits (preparation, implementation, report)
- Total quality management and quality management tools with quality techniques like KVP / CIP, PDCA
- Risk management (ISO 14971)
Quality assurance
- Design control incl. design validation
- Risk based process qualification or validation
- Equipment and test equipment qualifications, validation of test methods or computer systems
- Supplier management (qualification, monitoring, audits)
- CAPA management
- Document management
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