CE Mark Certification
As 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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Electronic Manufacturing Services (EMS)
- 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.
- 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
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