Qualification profiles
MD SERVICE
Manfred Lubberich
Graduate Engineer Chemistry & Biotechnology
Experience
20+ years experience in Quality-Management and Regulatory within Medical Device, Pharma, IT 20+ years international Leadership Experience within a Sales, Design, Production, Engineering, Laboratory and Service environment Deep know-how in the Management Systems EU (EU-MDR 2017/745, EU-IVDR 2017/746, EU 2023/607, 93/42/EEC, 98/79/EC), MDSAP, ISO 13485, ISO 14971, country specific laws, CFR Title 21 (such as 3,4,200, 600, 820) GMP, cGMP, ISO 9001) Logistics: EU GDP EU FMD, Chemikaliengesetz (ChemG, Deutschland) Auditor ISO 13485, supervision of inspections and audits, ISO 9001 Project Management know-how and experience FDA readiness Vigilance and Post Market Surveillance CAPA and Complaint Management acc. MDR/IVDR/CFR820/CFR11/ISO13485 Risk Management acc. ISO 14971 Supplier Development Registrations in EU, USA, Australia, CIS, Middle East, Asia, South America, Africa MD SERVICE
Rolf Stegmayer
Master Process Engineering 3th party Certification Auditor ISO 13485 Operational Six Sigma Black Belt
Experience
> 32 years’ experience in Quality-Management and Regulatory within Medical Device, Pharma, Automotive, Electronics and Machinery Engineering industries > 29 years’ international Leadership Experience within a Sales, Design, Production, Engineering, Service and Rental environment > 21 years’ experience with Six Sigma, Lean, Kaizen, Kanban, TPS, Value Stream Mapping and further LEAN-tools as Operational Black Belt Deep know-how in the Management Systems QSR21CFRx, MDR, IVDR, ISO13485, MDSAP, ISO9001 and TS16949 3th party Certification Auditor for the standards ISO 13485 and ISO 9001 Project Management know-how and experience FDA & NMPA readiness Process and Cleaning Validation Validation of Sterilization Processes CSV / Computer Software Validation CAPA and Complaint Management Transport- and Packaging Validation Risk Management acc. ISO 14971 Audits acc. to ISO 13485 and MDR requirements Supplier Sourcing and Development Registrations in CE, US, Africa and GCC Good Distribution Practice