GENERAL MEDICAL DEVICES
Medical Devices are present in our daily lives now more than ever and that is why manufacturers and distributors seek to give greater guarantees of safety and quality in their products.
The Medical Devices category is broad, including very different products whose classification is governed by the risk they pose to the people who use them. Products must be manufactured following a quality management system (UNE 13485: 2018) and it is important to know the product and the standardized rules applicable to it, in order to analyze and guarantee its compliance.
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.
From Bionok we offer you all the necessary services to develop your Medical devices guiding you throughout the entire process:
– Design and development, for its adaptation to the regulations.
– Advice and development of clinical safety and efficacy tests.
– Elaboration of required scientific-technical dossiers.
– Quality systems.
– Presentation before authorities or evaluation centers.
– Representative or Authorized Agent.
– Place on the market.
Medical devices must have on their labeling an authorized Representative or Agent in order to be marketed (Ex.: EU, CHINA, USA). This figure must guarantee the conformity of the product and is responsible for its placing on the market.
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.
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