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ISO 13485 PROCEDURES

Iso 13485 Medical Devices Quality Management System Standard should not be provided.

► The norms and legal conditions of the relevant product, if any, should be investigated.

► Medical device risk analysis according to the ISO 14971 standard

► Taking Iso 13485 General training

► Training for Iso 13485 internal auditors

► Assigning task, authorization and responsibilities for Iso 13485

► Planning of Iso 13485 documents

► Determination of hygiene rules regarding the use of the product within Iso 13485

► Iso 13485 assessment of work-related risk factors

► Measuring customer satisfaction

► Writing iso 13485 procedures

► Writing process instructions

► Creation of Iso 13485 internal audit plans

► Conducting Iso 13485 internal audit

► Conducting Iso 13485 Management Review

► Making application for Iso 13485 certification

 

Certification

The firm, which provides auditing, supervision and certification services to internationally recognized standards, also provides periodic inspection, testing and control services.

Contact Us

Address:

Mahmutbey Mh, Dilmenler Cd, No 2 
Bagcilar - Istanbul, TURKEY

Telephone :

+90 212 702 00 00

Whatsapp:

+90 532 281 01 42

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