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CE MARKING IN VITRO DIAGNOSTIC DEVICES
ISOplan offers hands-on assistance on all aspects of the CE marking of the IVD.
We
provide support in the following areas:
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Product
classification
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Advice
on regulatory strategy for conformity assessment
procedure
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Self-Certification
package for Annex III IVD Products
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Development
and implementation of QM system
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Product
evaluation and clinical testing
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Preparation
of technical product documentation or registration files
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Certification
by Notified Body (only for selected product categories
like Annex II products) or EC-declaration of conformity
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Functioning
as your Authorized European Representative
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Development
of a Complaint Reporting System
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Consultancy for medical and healthcare companies
Scriveteci