Dear Pongsiri,
Christophe Bosshart forwarded me your request for an FSC sample + CE mark + ISO 13485 certificate if I understood well.
I attached unsigned copies of these documents as samples for you. If we progress with registration, we will need to officially get these documents signed by our health authorities. This process will take around 5 weeks.
Before starting any registration work, we ask our future partners to fill in the attached questionnaire (F-REGQU – Ed2)as part of our quality / regulatory assessment. Please can you fill it and send it back to me as soon as possible if you wish to proceed with registration.
I thank you in advance for your reply and hope to start a collaboration with you soon
Monique
Monique BERWAER
Regulatory Affairs Specialist