Hello. Ladies and Gentlemen.
I am Jason, Marketer of iiSM Inc. :)
We, iiSM Inc., recently achieved ISO 13485 and CE mark.
Frankly, we already obtained them two months ago.
Please forgive that the time finally allowed me to update this news today.
ISO 13485 is certification regarding Quality management system.
It is based on ISO 9001 and is international standard of medical device made from special requests for medical device.
Yeah… I know it's kind of boring.
Anyway, from ISO 13485 certification, our medical products including Vein Probe, are guaranteed that they are manufactured following the strict quality management system.
Next, we obtained CE mark for Vein Probe Desk type.
CE is abbreviation of French word, 'Conformite Europeenne', which means European communities; EC.
It is a comprehensive certification mark used in EU market for the safety of the products.
We have been preparing CE mark for breaking into European market.
We will obtain CE mark for not only Vein Probe Desk type but also Vein Probe Compact type and Stand type.
It will be this June for us to obtain CE mark for both types.
What is more! Vein Probe is also registered at FDA(USA), CFDA(China) and PMDA(Japan).
Again, Vein Probe is manufactured through strict quality management system.
We promise you that we will get other safety certifications as well.
When you use our product, you don't need to be worried at all! :)
For more details, you can check through our blog. (Link below)