- Internal Audit
- ISO 10002
- ISO 13485
- ISO 27001
- ISO 45001
- ISO 9001
There are two ISO 10993-5 & ISO 10993-10 testings which are critical when applying CE Registration.
In the market, most of consumers focus the percentage of BFE & VFE, Class / type of Face Mask, the product of origin….
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.
The BANK OF EAST ASIA awarded ISO 10002 Quality Management – Customer Satisfaction certification covering its Productivity and Service Quality Department by SGS Hong Kong in Dec 2020.
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.