thomascsyu

Immigration Department awarded ISO 9001 and ISO 10002 Certifications

Immigration Department awarded ISO 9001 & ISO 10002 Certifications

Immigration Department’s Management Audit Section awarded ISO 9001 & ISO 10002 Certifications The Immigration Department’s Management Audit Section is ISO 9001:2015 and ISO 10002:2018 certified in Dec 2020. Being the first ISO certified section in the Immigration Department, these two certifications are attaching the importance to the quality assurance and public relations in the Immigration …

Immigration Department awarded ISO 9001 & ISO 10002 Certifications Read More »

UKCA Marking

UKCA Marking

The UK Government have introduced new UKCA conformity marking to replace CE Marking, and this will effective on 1st Jan 2021. The new UKCA Marking requirement will be used for products being placed on the market in Great Britain (England, Wales and Scotland), replacing the EU requirements for CE Marking.

KN 95 CE Certification

Steps 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 KN95 Face Mask. The EU Medical Device Directive /Medical Device Regulation and Personal Protective Equipment Regulation control and regulate the import and sales of Face Mask in Europe. The below table show the different regulations between China Regulation and EU …

Steps Guide to import China KN95 Face Mask to EU Countries Read More »

CE Mark 認證

【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.

FSC COC Certification Raise Print

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.

ISO 13485

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.