logo

OUR SERVICES
CONTACT US TODAY FOR A FREE QUOTE

Our services

When a company intends to bring its medical device onto the European market it will have to ensure that the appropriate procedures for assessing the conformity with the European medical device  legislation have been carried out. The to be followed conformity assessment procedure depend on the intended use and the classification of the medical device itself. The following steps are to be taken to certify your medical device.

The following steps are to be taken to certify your medical device

  • Classification of the medical device.
  • Selection of the relevant conformity procedure.
  • Drawing up and assessing the Technical Documentation.
  • Assessment of the quality system.
  • Assessment of the components from suppliers.
  • Drafting an EU Declaration of Conformity and affixing the CE marking.
  • Registering the medical device with the competent authority.

  • CE-Marking for medical devices

    CE certification of medical devices is mandatory. Medical devices that fall under the European New Approach Directives (EU Directive 93/42/EEC) and the regulations must be CE certified.

    READ MORE

  • Product Testing

    One of the general obligations for manufacturers of medical devices is that they shall ensure that the medical devices have been designed and manufactured in accordance with the applicable legislation.
    READ MORE

  • Technical Documentation

    Part of every conformity assessment procedure of medical devices is the composing of the Technical Documentation. One of the general obligations for manufacturers of medical devices is that they shall draw up the Technical Documentation.
    READ MORE

  • Clinical evaluation

    A general obligation of manufacturers of medical devices is to conduct a clinical evaluation. The extent of the clinical evaluation is dependant upon the exact specifications, intended use and used materials of the medical device.
    READ MORE

  • QMS compliance

    Our Quality Assurance experts are trained professionals in the guidance and implementation of QMS compliance, mainly on ISO 13485:2016


    READ MORE

  • Private Label

    Private labelling is a much used phenomenon in the medical device industry. Private labelling means to bring a product from another manufacturer onto the European market under your own brand name.

    READ MORE

    • Request an offer today!

    GET A QUOTE

    About Us

    Follow us

    Visit Us On TwitterVisit Us On Linkedin
    © 2018 CE Medical. All rights reserved.