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.

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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.

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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.

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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.

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ISO 9001 Consultant

3 Tips for implementation of ISO 9001

When your company can fulfil ISO 9001 Clause 4.0 context of the organisation, the pain point is how to identify risk & opportunity
Firstly, the ISO 9001 standard did not require company to define Risk Assessment or Risk Level.

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