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