Carla Kikken-Jussen 398 connections

President CEO MEDITECH Strat..., EU Medical Device CRO

Vaals, the Netherlands

Contact Info

(work)

Phone

+31620596733 (work mobile)

+31433063320 (work)

Website

www.meditech.nl (work)

Work/Education

Work Experience

EU Medical Device CRO / President CEO MEDITECH Strat. Consultants

2000 - Present

I started MediTech in 2000, after 20+ years in medical devices covering CLINREG/QUALITY.
Working with mainly US companies - the majority of them being start ups - we work with them to guide them through the regulatory proces in order to obtain CE Mark. Which grants market access to all of the 27 Member States of the EU.
We take care of Clinical Monitoring (GCP/ISO 14155) as well as relevant IRB/CA submissions.

Bioplex Collagen Products Division / Senior Clinical/Regulatory/Quality responsible for EU submissions

1996 - 1999

Datascope BV Netherlands Ass Director / Asst Director Manufacturing, responsible for daily plant running

1985 - 1996

Lawyer Office Maastricht / ParaLegal

1980 - 1985

Lawyer Office Heerlen / ParaLegal

1973 - 1980

Education

University Maastricht

Colloquium Doctum, 1984

University Utrecht Law

Bachelor Law, 1982

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Carla Kikken-Jussen updated Work on her profile Aug 17, 2009

Updated company

Asst Director Manufacturing, responsible for daily plant running, Datascope BV Netherlands Ass Director (1985-1996)

Carla Kikken-Jussen updated her profile Mar 22, 2009

New favorite music	Opera (La Boheme, Carmen, Lohengrin), Musical (Phantom, Cat...
New interests	my job/company, books, movies, travel, history, Greek Mythol...

Carla Kikken-Jussen updated her profile Mar 21, 2009

New favorite TV shows and movies	Science Fiction: Star Trek, Next Generation, Detectives, In...
New favorite books	Da Vinci Code, Agatha Christie, Mists of Avalon,
New home town	Vaals, Netherlands
New interests	my job/company, books, movies, travel

Carla Kikken-Jussen updated Work and Education on her profile Mar 5, 2009

Updated company	NEN Dutch Standardization Institute Working Group Tissue and Medical Devices (Weefsel en Medische Hulpmidden) (1993-Present)
New company	Technical Committee 316 European Commission, Risk Analysis Docs Animal Origin Products (1993-Present)
New company	Member of the Dutch Standardization Institute Working Documents on Risk Analysis (2009-Present)
Updated company	President CEO MEDITECH Strat. Consultants, EU Medical Device CRO (2000-Present) I started MediTech in 2000, after 20+ years in medical devices covering CLINREG/QUALITY. Working with mainly US companies - the majority ... more>
Updated school	University Utrecht Law (1982) Bachelor Law
Updated school	University Maastricht (1984) Colloquium Doctum