Alfred Zahner

Setup Businessprozess, TQM, PDCA Managementprocess Regulatory Affairs MDR 2017:745, Riskmanagement File 14971:2019, ISO/TR 24971:2020-(06), FMEA, CAPA

MDR 2017:745 Compliance: Riskmanagement File 14971:2019, ISO/TR 24971:2020-(06), FMEA, CAPA

research to sterile and bulk packaging solution, scientific tests and data analysis for glass cartridges and syringes, closures, nests and barrels; result evaluation; create TR; URS for RTUC- Platform (ready to use, from glass to dug filling and closing); Risk Management ISO 14971 / D-FMEA controlling and preventive; ISO 15378:2017 packaging, ISO 695/DIN 12116 chemical resistance,

MDSAP preparation / audit, upgrade MDD to MDR standard, remediation overall supply chain, SCM analysis, supplier qualification, definition critical supplier criteria, implementation RFI / RFQ, training procurement staff, investigation / gap DMR file

Request / Assessment STED Documents from Legal Manufacturer and Supplier, Liaison with Supplier for Registration Purpose worldwide, Evaluation of legalized and apostilled EC-FQA Certificate MDD 93/42, ISO 13485 and DoC, initiate and monitor Process Changes, Coordination Re-registration Activities

FDA CFR 21 Part 820, ISO13485, MDD 93/42/EEC, Technical Files/Design Dossiers DHF, DMR-File, Risk Management ISO 14971 / D-P-FMEA, Software EN 62304, Usability IEC 62366, IEC 60601-xx, Submission RA Dossiers (CE, CSA, FDA 510(k), Canadian Health,..), FDA / CSA / CE Audits, Process Validation (DQ, IQ, OQ, PQ)

Companies: DePuy Synthes (J&J), Zimmer Biomet Ltd. DHF, DCTM, MDD 93/24, FDA CFR 21 Part 820, Risk Management ISO 14971, GPM Validation, CAPA Engineer, TQM Processleader

Regulatory Affairs (MDD, EN, FDA, EEC), TQM, Development embedded Systems, LEAN Management, OEM Agreement Business, Technology Transfers, Factory Relocation

SLA/SMA International, Testmanager, Changemanagement, LCM, Helpdesk-Callcenter, Release-Configurationmanagement

SAP ERP upGrade, Outsourcing BAO-BPO, SLA Account Manager, Change Process