- Country: Finland
- Summary: Medical Device Process Consulting Services
- FIT Ref No: 83084630
- Deadline: 17 May 2024
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 294971-2023
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- Description:
- Istekki Oy (Customer) has developed a quality system related to the manufacture of medical devices and started manufacturing medical devices (applications). In connection with this, the Customer plans the manufacture of medical devices for regulation (Medical Device Regulation, MDR) and laobtaining a consultation related to the atu system (ISO 13485). The consultation will be used especially for the continuous development of operating models and the quality system (ISO 13485) for the manufacture of medical devices, as well as to support the development of new CE-marked medical devices.
Hthe consultation service provided is used e.g. in relation to the following tasks:
• Development of a quality system according to ISO 13485
• Consulting the content of the product's technical file for CE marking
• Development of the sw development process according to IEC 62304 and agile development models
• Verification and varegistration processes for the product
• risk management according to ISO 14971
• definition and development of clinical evaluation processes
• validation of information systems
• Eudamed registrations and processes and requirements related to the UDI identifier
• assistance in dealing with the notified body, itcertification process
• Identification and classification of medical devices
• Evaluation of existing products from the point of view of MDR
• Consulting product reviews of the product development process from the perspective of quality and MDR
• Preparation of the declaration of conformity
• Information on medical devices... - Documents:
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CLICK HERE TO LOGINMedical Device Process Consulting Services - Finland Tender
The ISTEKKI OY, a Government sector organization in Finland, has announced a new tender for Medical Device Process Consulting Services. This tender is published on FinlandTenders under FIT Ref No: 83084630 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-05-17.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
