Laura Rossing
Regulatory Affairs
Produktregistrering (CE, RoW)
Projekt koordinering
Dokument skrivning/generering
Oversættelser
Konsulenter
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Camilla Wamberg Munkesø
Regulatory Affairs
Class III and Combination Products
Product development
Clinical Evaluation
RA/QA leadership
Rasmus Rask Walther
GMP Projektledelse
Vendor selection
Renrums produktion
Risk Management
Validering
Hans-Ole Hansen
General / Vendor & Project Management
Equipment specification & installation under GMP
Product development & production implementation
Validation (also with statistical methods)
Problem solving and road block removal
Rene Pihl
Projektledelse
Installation & validering
Teknisk udvikling
Specifikation & implementering
Lean 6 sigma
Marianne Myhre
Ledelse & organisationsudvikling
Organisations- & kulturanalyser
Optimerings- & udviklingsprojekter
Proces, vision & strategi
Coaching - Teams & Individuelt
Tommy Roy Røsholt
Program and Project management
Unique Device Identification (UDI)
Regulatory Master data
Labelling strategy
MDR and IVDR
Charlotte Borgensgaard
Ledelse og Projektledelse
QA, QC & Regulatory Affairs
Risk Management
Proces- & softwarevalidering
Renrumsproduktion
Jens Kristian Petersen
QA
RA (CE mærkning, FDA510k, Sundhedsstyrelsen)
Proces
Programmering
Validering
Steen Guldager Petersen
Design control & medical devices: ISO 13485 & 21 CFR 820
Project management, Prince2 certification
Verification, production transfer and validation
Risk management according to ISO 14971
Biochemistry, molecular and cellular biology