ISO INSIGHT
How to get [CE Mark] for Hand Sanitizer
Hand Sanitizer / Hand Gel can be exported to EU market according to Cosmetics Regulation (EC) No 1223/2009 or Biocides Product Regulation (EU) 528/2012
Steps Guide to import China KN95 Face Mask to EU Countries
Guide to import China KN95 Face Mask to EU Countries In China, there are two major type of Face Mask- 3 ply Face Mask and
【CE Mark】| 5 Steps to get CE Mark
CE Mark registration
If the medical device is manufactured in the EU country, the manufacturer can apply directly to the local government agency (Competent Authority). If the medical device is manufacture outside of EU, the EU authorized Representative assists the manufacturer to apply CE Registration.
How to conduct ISO Internal Audit
According ISO 19011 requirement, Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
CASE STUDY | Raise Print
One big of their Client requested RaisePrint to get FSC Certification and provide FSC Certified printed packaging for coming order. If RaisePrint could not get FSC Certificate, they may lose this client and a certain sales volume. They had no idea about FSC Certification how to comply and apply.
Mask Production and ISO13485
ISO 13485 is a quality management system standard for medical devices, which comes from the ISO 9001 quality management system standard. ISO 13485 ensures that manufacturers continue to design, develop, produce, install and deliver safely and in compliance with relevant regulatory requirements and the intended purpose of medical devices.
