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Bergenthal Consulting

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• 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

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