DAHLFELT CONSULTING Aps


Vi sikrer I er i compliance






DAHLFELT CONSULTING 


Tilbyder markedets mest erfarne senior konsulenter indenfor

Medical Device, IVDR, Pharma, kombinations-produkter


Hos Dahlfelt Consulting er alle vore konsulenter Seniorer/Specialister med min 15-25 års erfaring indenfor deres fagområde.


De er alle udadvendte og kommunikerende med alle niveauer af organisationen. Deres kompetencer og erfaringer i top. De er selvkørende og tager ansvar, udfordrer og optimerer det etablerede for at skabe bedre overblik og fremdrift i jeres projekter.


Vi leverer en standard udover det sædvanlige inden for:

                                                    

  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • GAP - Analyse
  • Clinical Trial
  • Risk management
  • Projektledelse
  • IT - PAS-X – MES - Scrum
  • Software documentation, validation
  • Validering
  • Audit - internal & supplier
  • EHS, Safety
  • Sterilisation

THE SENIOR TEAM

BIRGITTE ENGELSEN

Labelling, IFU, RA and PM

ALEXANDRA TORRES SOMMER

QA, Risk, Product and Project management

SØREN ROOED PEDERSEN

Validation, QA, Sterilisation, Aseptic and Project management

TIM DAMGAARD CHRISTENSEN

Projektleder, QA, MDR, Submission 510K & QMS

BJARNE JENSEN - Ride On Power Mind

Project management, IT, PAS-X & MES

LISBETH SEJER

MDR, IVDR, RA, QA, Vigilance, Labeling  and Submissions

PHAT HUYNH

QA, QC, RA, Risk, IT, Sterilisation and Project management

ANJA TOFT ENDERSLEV

QA & CLINICAL

LIL ORSINI

QA, QC, Lead Auditor

TORBEN DAHLFELT

PROJECT MANAGER and CEO

PERNILLE DISSING - Nordic BioConsulting

QA, QC, Clinical and Project management

PER HAGSTRØM - PJNN Consult

Program-, Process- and Project management

CHARLOTTE VISSING - ChampQ Consult

Validation, QA and Audit

LENE BASTHOLM

Risk, QA and Lead Auditor

TOM ANDERSEN - QualityVision

Risk, QA, QC QMS, Lead Auditor and Project management

HENRIK LINNEMANN - HBL Consult Aps.

Validation & QA

VERA BERNADETTE HOOGLANDER

IT system exspert, MES & ERP

ANNE DAMM

QA, Risk, Projektledelse

KLAUS R. ANDERSEN - Tele Technology

Software developmpent & documentation

GITTE FUGLSANG-FOG

QA, QC, RISK, QMS and Veeva

STINE DAHLFELT

Officemanager & Communication