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How to Authenticate the CE of Medical Equipment and What Materials Are Needed?

  Author:MeCan Medical–ultrasound machine manufacturers

What do you need to do for medical device CE certification? It is clearly stipulated in EU laws that all imported medical devices must be carried out by medical device CE certification. This must be passed, but there are many types of medical equipment. The equipment is roughly divided into three categories of "1, 2A, 2B, and Class 3" categories of medical devices. "CE logo can be adopted by the CE logo; The CE logo must be verified by the verification agency designated by the European Union, and the prerequisite for these types of products to obtain CE certification is that the manufacturer needs to pass the ISO9000ISO13485 quality system certification, that is, obtains the ISO9000issued by the EU's certification agency, issued by the EU, issued by the EU, issued by the EU9000 ISO13485 Quality System Certification Certificate. If you want medical device products to pass CE certification, which materials need to be prepared?

1. Do a good job in the standards and certification materials required by EU regulations on their products.

2. The technical requirements of the manufacturer are different from the EU technical regulations and EN standards.

3. The manufacturer's standard parts and maintenance quality systems are performed according to the ISO9000ISO13485 and have ISO9000ISO13485.

Medical equipment related to the health of the human body, so the European Union regulations have always been rigorous, and now there are strict regulations on the certification of medical device certification and compliance evaluation procedures that each announcement agency can engage in. When choosing an announcement agency, you must be very cautious to avoid unnecessary losses, draft a compliance statement, and add the CE logo.

How to Authenticate the CE of Medical Equipment and What Materials Are Needed? 1

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