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mi-CE consultancymi-CE consultanty
http://www.mi-ce.nl/
mi-CE consultanty
http://www.mi-ce.nl/
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mi-CE consultancy | mi-ce.nl Reviews
https://mi-ce.nl
mi-CE consultanty
Services | mi-CE consultancy
http://www.mi-ce.nl/services
CE Auditor - Contractor. Internal audits/ supplier and subcontractor audits. Offers several consultancy services for medical device manufacturers, in vitro diagnostic devices, and related companies (suppliers) to guide you trough the mash of regulatory requirements for entering the market. Due to the broad experience of the project managers, mi-CE consultancy. Mi-CE consultancy Services :. Consultancy for Design History Files/ Technical Dossiers and regulatory complaince. Medical Device Directive (MDD).
News / Updates | mi-CE consultancy
http://www.mi-ce.nl/news
Updates on Directives/ guidance documents:. Published proposals by EU commission for new regulations. Medical devices and IVD's, expected effective date: early 2015. To the proposed revised IVDD. MEDDEV on standalone software. Publication of the titles and references of harmonised standards under de directives ( pdf. List1 and List 2 of the Medical devices standards is updated. Dutch standardisation site ( NEN site. September, 2013: HAT conference. Papendal, the Netherlands.
Concept | mi-CE consultancy
http://www.mi-ce.nl/concept
Offers complete (including Clinical) consultancy services for medical device and in vitro diagnostic (IVD) manufacturers for CE marking compliances according to the MDD and IVDD. Is expert in Quality Management System set-up to be in compliance with the requirements of ISO 13485:2003, ISO 9001:2008 and ISO 13485:2003 under CMDCAS (Canadian) and for Taiwan. Also performs CE/QMS compliance audits and design dossier/technical dossier reviews for notified bodies. Meeting the standards, leading the way.
Links | mi-CE consultancy
http://www.mi-ce.nl/links
Presentation University Hospital UMCN Radboud, department Valorisation: jan 2011. (pdf version). Meeting the standards, leading the way.
About us | mi-CE consultancy
http://www.mi-ce.nl/people
Has consultants (with PhDs and MDs) with special experience in regulatory requirements for In Vitro Diagnostic Devices, all kinds of Medical Devices, including the so-called "borderline devices" and clinical evaluations. The management team consist of:. Anja Wiersma and Siert Knollema. Anja Wiersma, PhD. CEO and senior consultant. She started her own consultancy mi-CE consultancy. For medical device and in vitro. Diagnostic device manufacturers, and remains a contractor for notified bodies executing.
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Dr Harrell has more than 15 years of experience working with adolescents and adults who present with a variety of psychological challenges. She specializes in the treatment of Obsessive-Compulsive Disorder (OCD) and Trichotillomania and has extensive experience working with Panic Disorder, Phobias and Generalized Anxiety Disorder. Website Designed at Homestead Design a Website. And List Your Business.
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mi-CE consultancy
In Vitro Diagnostic Devices. Your regulatory compliance consultant for Medical Devices, In Vitro Diagnostics, CE marking, Clinical Evaluation and Clinical Trial Design reviews. MEETING THE STANDARDS, LEADING THE WAY is our mission. Has a special focus on the 3 main regulatory compliance topics for:. In Vitro Diagnostic Devices. Meeting the standards, leading the way.
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