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ISO 13485 is a regulated quality management system for medical devices, and its standard items are enriched for medical devices and customized for medical devices. Medical Device CE Certificate is a regulation created by the European Union Commission that medical device manufacturers are obliged to comply. The final version of ISO 13485 was published in February 2016. The ISO 13485: 2016 standard has been updated for two important reasons. To comply with the changes in the industrial field and to refer to the changes highlighted in the ISO 9001: 2015 standard. Officially, the transition period is determined as 3 years. Firms must adapt their existing quality management systems to the requirements of ISO 13485: 2016 until February 28, 2019.
Recently, around 1500 comments and opinions were obtained from trade associations, manufacturers, academicians and individual experts through 2 public opinion polls; Many important inputs were obtained from these and included in the standard. The new ISO 13485: 2016 is applicable to the entire supply chain and covers the entire product life cycle of medical devices.

Some key changes for the final standard are as follows:
    • Harmonization of regulatory requirements
    • Incorporation of Risk Management into Quality Management Systems
    • More clarity and clarity on validity, verification and design
    • Strengthening supplier control processes
    • Increasing focus on feedback mechanism
    • Quality management standard, software for manufacturing and medical devices
ISO 13485: 2012 Certified Firms should plan their transition to ISO 13485: 2016 as follows and their preparations should be completed;
    • ISO 13485: 2003 and ISO 13485: must perform an analysis of the difference between 2016 or ISO 13485: 2016 should receive the training,
    • transition training for those responsible about the organization should be completed,
    • ISO 13485: by 2016 should be planned activities to be carried out,
    • Related documents revised according to new standards
    • It should implement its applications and create records according to the ISO 13485: 2016 standard ,
    • It should create technical files for first class devices according to the scope of the medical device directive.
The general purpose of the standard; It determines the requirements of a Quality Management System that can be used by an organization for the design, development and provision of services related to the design and development, production, facility and service of medical devices. In addition, this standard can be used by internal and external organizations, including certification bodies that evaluate the organization's ability to meet customer and regulatory requirements. The quality management system conditions specified in the standard are complementary to the technical requirements of the product.

Benefits of TS EN ISO 13485 Medical Devices Quality Management System;
    • Providing competitive advantage,
    • Increasing the reputation of the organization in the market ,
    • Establishing the infrastructure that will ensure the standardization of business activities,
    • Protection of human health depending on the increase in the quality of the devices,
    • Increasing the quality awareness of the employees,
    • Ensuring the global compliance of medical devices with the quality rules,
    • Design of medical devices, Increasing the quality of production and service,
    • Providing advantage especially in exports to European Union countries,
    • Increasing the confidence in devices,
    • Facilitating compliance with various laws and regulations on this issue.
The ISO 13485 Standard is the quality standard of the medical industry and covers all kinds of companies producing medical devices.
Before the ISO 13485 standard was published, there were the following standards that covered medical device manufacturers, but were repealed today:
    • TS EN 46001 Quality systems-Medical devices-Special rules for the implementation of the EN 29001 standard
    • TS EN 46002 Quality systems-Medical devices-Special rules for the implementation of the EN 29002 standard
Both standards defined the quality system requirements for the production of medical devices and their installation where appropriate. ISO 13485 Medical Devices Quality Management System has been established in order to implement these two standards together with the ISO 9001 Quality Management System standard. The most important practical benefit of companies producing medical devices to establish and manage this system in their businesses is that it forms the basis of the CE marking system, which is mandatory for all medical devices. In other words, all manufacturer companies that want to obtain CE certification for their products have to start by establishing the ISO 13485 standard.

ISO 13485 Medical Devices Management System Certificate
The certification of the ISO 13485 standard covers the quality management system requirements for an organization that must demonstrate its ability to provide medical devices and consistently meet customer needs and regulatory requirements applicable to medical-related services. This document; It can ensure that medical device manufacturers, warehousing, semi-finished products and service providers, in short, all companies in the medical sector attain international reputation, trust, respectability and acceptability. ISO 13485: 2016 Standard today; It can be seen as the only international tool for manufacturers, importers, exporters and distributors to meet legal requirements.

The organization or firm that wants to obtain the certificate of this standard;
    • Obtain and examine the document for this standard,
    • Determine the scope to apply this standard,
    • Create a Quality Management System according to this standard,
    • Operate the quality management system prepared in accordance with the ISO 13485 Standard, and create the necessary records,
    • Giving the ISO 13485 Standard They must apply to an authorized and accredited institution and submit their documents, and then enter the audits to be carried out by this institution,
    correct any nonconformities and complete these audits,
    • Participate in periodic audits if necessary to ensure the continuity of the document received, close the nonconformities, and leave these audits successfully.
"As KAS Certification Body, you can contact us to benefit from the service we provide within the scope of ISO 13485 Medical Devices Management System standard and to have detailed information."

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