Bergenthal Consulting

• Product submissions (e.g. FDA 510(k) or CE marking) • Review of Technical Documentation (e.g. STED or EU MDR) • Risk management according to ISO 14971 • Software development according to EN 62304 and EN 82304-1 • Artificial Intelligence (AI) and Machine Learning (ML) • Software as a Medical Device (SaMD) and Software as a Service (SaaS) • Cloud and mobile devices • Process optimizations and process interfaces across the Quality Management System (QMS) • Document control • Internal and external audits like EU MDR, MDSAP, or FDA inspections (frontroom/backroom) • Supplier management and supplier audits • Corrective and Preventive Actions (CAPA) • Remediation • Tool Validation • Complaint Handling and Vigilance • Field Actions and Recalls • Non-conformities • Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC) • Project support and planning