Konsulenter

Her finder du vores tilknyttede konsulentvirksomheder

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RAQA ApS

RAQA ApS

Laura Rossing

Regulatory Affairs

Produktregistrering (CE, RoW)

Projekt koordinering

Dokument skrivning/generering

Oversættelser

Medical Device Advice

Medical Device Advice

Camilla Wamberg Munkesø

Regulatory Affairs

Class III and Combination Products

Product development

Clinical Evaluation

RA/QA leadership

BluePuffin ApS

BluePuffin ApS

Rasmus Rask Walther

GMP Projektledelse

Vendor selection

Renrums produktion

Risk Management

Validering

DBJ Development

DBJ Development

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

SinCop DK

SinCop DK

Rene Pihl

Projektledelse

Installation & validering

Teknisk udvikling

Specifikation & implementering

Lean 6 sigma

MYHRE REFLECTIONS

MYHRE REFLECTIONS

Marianne Myhre

Ledelse & organisationsudvikling

Organisations- & kulturanalyser

Optimerings- & udviklingsprojekter

Proces, vision & strategi

Coaching - Teams & Individuelt

Rosholt Consulting

Rosholt Consulting

Tommy Roy Røsholt

Program and Project management

Unique Device Identification (UDI)

Regulatory Master data

Labelling strategy

MDR and IVDR

Borgensgaard Consulting

Borgensgaard Consulting

Charlotte Borgensgaard

Ledelse og Projektledelse

QA, QC & Regulatory Affairs

Risk Management

Proces- & softwarevalidering

Renrumsproduktion

KM Consulting House

KM Consulting House

Jens Kristian Petersen

QA

RA (CE mærkning, FDA510k, Sundhedsstyrelsen)

Proces

Programmering

Validering

Life Science Progress

Life Science Progress

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