Europe CE marking

C-REG Medical guides your company onto the European market (93/42/CE, 98/79/CE, etc...)

A high-level experience on medical devices and in-vitro devices allows me to address your needs whatever the directive.

90/385/CE : Implantable medical devices (active)
93/42/CE : Medical devices

            2000/70/CE : medical devices with blood/plasma derivatives
            2003/12/CE : reclassification of breast implants
        2003/32/CE : medical devices manufactured with animal products
          2005/50/CE : reclassification of articular implants
          2007/47/CE : update of 90/385/CEE, 93/42/CEE, 98/8/CE,…

98/79/CE : in-vitro diagnostics

I can assist you on a wide variety of issues to comply with European requirements:

determining the correct product classification

identifiying appropriate conformity assessment routes to the CE marking

developing the Technical File (Essential Requirements, Declaration of Conformity ...)

assuring that Risk Analysis requirements are met (ISO 14971)

creating and implementing a quality system (ISO 9001, ISO 13485)

assisting with Competent Authority Inspections

completing Internal Quality Assurance Audits

interfacing with Competent Authorities

complying with the post-market requirements including vigilance systems for Users, Distributors and Agencies

supporting Clinical Studies for the CE marking

personalised surveillance of regulatory evolutions

Many other European directives are related to Medical Devices such as the WEEE / ROHS Directives:
C-REG Medical can help you determine which directives apply to you and how to ensure conformity.

Have you thought about training ?

Your regulatory issues could be first addressed by training your team involved in the CE marking.
Any training program will be tailored to your needs, taking the profile of your team into account.

For more details or to discuss other projects, please contact C-REG Medical.

Tim Lawton
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