CE Conformity
For the devices in the portfolio, manufacturer declarations, conformity certificates and intended-use documentation are shared with procurement files.
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01 Certification
Traceability in medical device supply and document integrity.
Regulatory status and the technical documentation requested by the institution are verified separately for each product family.
Quality Management
Manufacturer and supply chain quality processes are documented in line with institutions' quality management and audit requirements.
Ministry of Health / ÜTS
Product tracking system records, lot/serial tracking and delivery documents are managed in accordance with medical device regulations.
Authorisation Certificates
Distributor and representation authorisation certificates are provided in the format required by the tender or hospital procurement process.
Technical Files
Brochures, instructions for use, technical specification forms and surgical accessory lists are prepared by product category.
Data Privacy
Physician, hospital and patient-related information is processed only to the extent required by quotation, training and supply processes.
Let us deliver the document set in your institution's format.
Tell us which product family and which document format you need, and we will compile the file accordingly.