返回Dongguan Simzo Electronics is a professional R & D, production and sales of home medical equipment company,
products include electronic thermometer, infrared thermometer, ultrasonic nebuliser, compression nebuliser and so
on.
Based on the previous cooperation, the customer signed a long-term strategic consulting contract with our company,
and entrusted our company to provide counselling for the CE registration of new products (electronic thermometers),
the maintenance of CE technical documents of old products, and the certification of ISO 13485:2016 version system.
After the contract was signed, our professional system consultant went to the customer's site to conduct tailor-made
training on ISO 13485:2016 system, process validation, risk management and other courses for the customer.
After the training, we counselled the client to improve and upgrade the existing system documents, and issued a full
set of system documents in time.
Meanwhile, during the process, according to the customer's production process and product characteristics, we
discussed with the customer and suggested the MDF, DHF and batch record list applicable to the customer, and
counselled the customer to establish a complete system.
During the pre-audit, our system consultant put forward in-depth practical and effective suggestions on the
customer's product inspection and testing, production process, development and design, which were unanimously
recognised by the management of the customer company.
During the audit, with the good preparation in the early stage and the customer's ability to master the system, we
successfully passed the ISO 13485:2016 system audit and got the conclusion of recommending the issuance of
certificates on the spot.
