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Determine Classification of Your Device

 

Determine if any directives apply to your product. Our specialists responsible for regulatory compliance, who possesses the requisite expertise regarding the regulatory requirements for medical devices in the European Union.

Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).


Assist in Third-Party Assessment

 

Medical devices with greater risks must be independently tested and certified by third-party organization in order to ensure their conformity with applicable essential requirements. 

  •   Quality Management System (QMS) according to EU ISO 13485

For most manufacturers, the QM system is the prerequisite for the conformity assessment. The technical documentation is also the subject of ISO 13485 audits.

  •   Product Testing

Select the applicable product standards and test methods for your product and select a Notified Body.

  •  Clinical Evaluation 

According to MEDDEV 2.7/1 rev4 and MDD (or MDR).

 

Support for Preparation of Technical File/Design Dossier

 

Our experts can assist in preparing and reviewing CE technical file for your medical devices takes precision and care, as the requirements for data, documentation, and formatting of this document are very specific. CE technical file Including:

 

  • ž Risk management file

  • ž Software file (software requirements, software architecture, tests)

  • ž Usability file

  • ž Clinical evaluation report (CER)

  • ž  Declaration of Conformity (DoC)

 

Update Technical Documentation to MDR

 

Under the new Medical Device Regulation (MDR) manufacturers need to establish and maintain a Technical Documentation as an evidence of conformity with the relevant legislation. Manufacturers should prepare to update their Technical Documentation to MDR. This is also true for manufacturers of class I devices that are not provided sterile, have no measuring function and are not reusable surgical instruments even though no involvement of a Notified Body is required.

 

Numerous product categories will require certification for the first time due to the Medical Devices Regulation's new classification criteria. GeBiao's functionality and the expert panel process to enable medical device companies to prepare for the upcoming changes.

 

Renewal Product Registration Annually

 

The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at least once a year when renew the product Certificate of Registration.

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