Declaration of conformity templates (medical devices 2025

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Elements Required in a GCC Identification of the product covered by this certificate. Citation to each CPSC product safety rule to which this product is being certified. Identification of the domestic manufacturer or importer certifying compliance of the product.
The Abu Dhabi Quality and Conformity Council is the government entity concerned with issuing a certificate for personals services that meet Abu Dhabi Occupational Terms and requirements as specified by the regulators.
The Declaration of Conformity document needs to include the following: Name/address of manufacturer (and of responsible person where applicable) Model and/or serial number of equipment. List of relevant directives. List of standards used, with dates + amendments. Declaration statement. Notified body details (if required)
Manufacturer/ importers identification such as the legal name, address and contact number. List of all safety regulations/standards that the product must pass. List of certificates awarded to manufacturer that the product has been tested and is compliant. The date and place where the product was manufactured.
Example: Statement: We, [Manufacturer Name], declare under our sole responsibility that the device [Device Name] conforms to the provisions of Regulation (EU) 2017/745 and the harmonized standards referenced in this declaration.
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A Quality Management System based on ISO 13485 helps to meet most of these review routes. 5) Declaration of conformity: This is the last step in which the supplier of the medical device confirms that the device fulfills all obligations identified in the relevant directives.
Yes, as a manufacturer, you have the responsibility and the authority to draft your own Declaration of Conformity (DoC) for your products.

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