EN ISO 13485:2016 Standard should be used as base for the establishment of the Quality Management System (KYS) for medical device producers.

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First of all, medical device producers should form the necessary infrastructure and work environment while using the necessities of the

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The validation of processes is one of the most slogged on issue among medical device producers. Medical device producers frequently confuse especially the validation, verification and revalidation concepts.

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First of all, medical device producers should conduct the classification of the product that they have produced with the consideration of the usage area, purpose of use and the product

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Medical device producers should prepare the Risk Management File for products that they have produced in compliance with the EN ISO 14971  Standard and based on

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In accordance with the Meddev 2.7.1 Rev 4 Guide, medical device producers should verify;
The clinical benefit
The clinical security
The clinical performance

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Post Market Surveillance (PMS), is the ensemble of the processes and activities to monitor the performance of a medical device. These activities are designed to produce information

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The medical device producer is responsible to prove that their medical devices would not cause any harm to the tissue in case it contacts with the tissue. Accordingly, biological assessment study should

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Medical device producers must complete the usability study in accordance with the structure of their medical device before releasing the product on the market.

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Producers that produce a medical device which consists of a software must finalize the software validation study in accordance with the EN

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