CE Mark Certification

ce marking technical filesAs part of our commitment to total customer satisfaction, we have achieved the internationally recognised quality standard ISO 9001:2008 and ISO 13485:2003 (Medical).

We are also accredited to the Medical Devices Direct 93/42/EEC, allowing us to CE mark non-invasive medical devices produced on behalf of our customers, removing the need for the customer to be CE approved.

A requirement of CE marking is to produce a technical file containing evidence that the product meets the required standard demanded by CE.  G&B can advise and assist customers with preparing the file for submission to the relevant authorities and to maintain the file throughout the life of the product.

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Telephone 01420 474188 | Email us

Benefits

  • Using G&B accreditation saves customers the expense and time of setting up and maintaining their own accreditation.
  • Helps your product to reach its market faster.
  • Enables customers to sell product into Europe, Canada, Japan, Norway and American markets assured that they comply with the required regulations.  Additional territories’ can be added as required.

Capabilities

  • CE Marking Product compliant with Medical Devices Directive Annex II (3)
  • CE Marking Commercial Products
  • Production of Product Technical Files
  • Production of test reports and certificates of compliance

Quality

G&B’s quality system details the procedures to complete the production of the Technical Files:-

  • declaration of conformity
  • instruction for use (user manual)
  • intended purpose
  • product life
  • manufacture and quality assurance specifications
  • product classification
  • applied standards
  • essential requirements
  • risk analysis
  • clinical data
  • design verification
  • draft label
  • review of technical file
  • maintenance of technical file

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  T: 01420 474188
  F: 01420 485277
  G&B Electronic Designs Ltd
  54 Woolmer Industrial Estate
  Bordon
  GU35 9QF

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