Qualification profiles

MD SERVICE

Manfred Lubberich

Graduate Engineer Chemistry & Biotechnology

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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