{"id":2723,"date":"2021-01-29T15:31:47","date_gmt":"2021-01-29T14:31:47","guid":{"rendered":"https:\/\/bionok.com\/active-implants\/"},"modified":"2021-03-04T17:06:22","modified_gmt":"2021-03-04T16:06:22","slug":"active-implants","status":"publish","type":"page","link":"https:\/\/bionok.com\/ko\/active-implants\/","title":{"rendered":"Active implants"},"content":{"rendered":"

[vc_row css=”.vc_custom_1606733631624{margin-top: 55px !important;}”][vc_column][vc_column_text]<\/p>\n

ACTIVE IMPLANTS<\/h1>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=”2419″ img_size=”full” el_id=”imagedesign”][vc_column_text]Active implants are the medical devices within the higher risk categories and are regulated according to the Active Implantable Medical Device (AIMD) Directive 90\/385\/EEC. These medical devices must be manufactured and assessed over very rigorous controls to ensure their safety.<\/p>\n

Manufacturers, importers and distributers must adapt their quality systems<\/u> to the specific requirements of these products which are usually more demanding.<\/p>\n

As any other Medical device, they require an Authorised Representative (EC REP) to represent the manufacturer (foreign or not) in front of the Authorities.<\/p>\n

For each product it will be necessary to study and analyze the aspects that determine its safety and efficacy. It is always advisable to create a strategy that makes the process as efficient as possible and in the shortest possible time.<\/p>\n

From Bionok we offer you all the necessary services to develop your Medical devices guiding you throughout the entire process:<\/p>\n

– Design and development, for its adaptation to the regulations.<\/p>\n

– Advice and development of clinical safety and efficacy tests.<\/p>\n

– Elaboration of required scientific-technical dossiers.<\/p>\n

– Quality systems.<\/p>\n

– Presentation before authorities or evaluation centers.<\/p>\n

– Labelled<\/p>\n

– Representative or Authorized Agent.<\/p>\n

– Place on the market.<\/p>\n

The Unique Device Identifier (UDI) is a numeric or alphanumeric code that identifies the medical device. This code consists of 2 parts: device identifier (DI) specific to a manufacturer and a product and a production identifier (PI) that identifies the production unit of the product. Bionok can help you get the UDI code for your Medical Device.[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1606726985955{margin-top: 0px !important;margin-bottom: 25px !important;border-top-width: 6px !important;border-top-color: #807002 !important;}” el_id=”contactview”][vc_column width=”1\/2″ css=”.vc_custom_1601110535248{border-left-width: 3px !important;border-left-color: #00184e !important;}”][vc_column_text css=”.vc_custom_1612874307265{border-left-width: 3px !important;border-left-color: #00184e !important;}”]<\/p>\n

Need help or have a question?<\/h4>\n

+34911371170<\/strong>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_btn title=”CONTACT US” style=”flat” shape=”square” color=”sandy-brown” size=”lg” align=”right” el_id=”buttons”][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1606729171993{margin-top: 45px !important;margin-bottom: 75px !important;}”][vc_column]

    <\/ul>\n[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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