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ISO 13485: 2016

Internationally approved and accredited;
ISO 13485 Quality Management System Certification and Certification Services for Medical Devices

ISO 13485 Quality Management System for Medical Devices

According to the Medical Device Regulation issued by the Ministry of Health, Pharmacological, immunological or metabolic means, but can be supported by their effects are called medical devices.

The pharmacological effect is the effect of drugs on living organisms such as humans or animals. This effect depends on the physical or chemical properties of the drug. The immunological effect is related to human immune systems. The immune system is a system that recognizes and destroys various organisms and cells that cause disease and protects against diseases in living things. Metabolic effect in living organisms It concerns all chemical reactions that occur during the maintenance of life. All living things have to take certain substances and energy from the external environment in order to maintain their vital conditions such as growth, development, movement or reproduction.

According to the Medical Device Regulation, medical devices are those devices that do not show these effects but can benefit from them during use. Then t covered by the regulationMedical devices can be counted as follows:

  • Medical devices used to diagnose a disease, monitor its course, treat the disease or reduce its effects
  • Medical devices used to diagnose, monitor, treat, mitigate, or eliminate grievances in the event of an injury or injury
  • Other medical devices used to investigate or alter any anatomical or physiological function in humans
  • Medical devices for contraception or medication only

The medical devices listed above may be used alone or in combination. It may also be used with computer software in parallel with today's developing technologies.

The cases where the Medical Device Regulation will not apply are also listed as follows:

  • In vitro medical diagnostic equipment
  • Active implantable medical devices covered by the Regulation on Implantable Active Medical Devices
  • Medical devices covered by the Regulation on Licensing of Medicinal Products for Human Use
  • Cosmetic products covered by the Cosmetic Law
  • Blood and blood products, except for human blood derivatives, plasma or blood cells and human cell, tissue, transplant organs or products manufactured using them
  • Tissues and cells of animal origin, other than medical devices, including inanimate animal tissues and products produced therefrom

This directive has been issued on the basis of the European Union directive 93 / 42 / EEC MDD. In addition, other regulations have been made in addition to this regulation. For example,

      Regulation on implantable active medical devices (European Union Directive 90 / 385 / EEC AIMDD)

      Regulation on In-Vitro Medical Diagnostic Devices (Directive 98 / 79 / EC IVDMDD of the European Union)

      Implementing Regulation on the Attachment and Use of the CE Conformity Mark to the Product

      Communiqué on Procedures and Principles Regarding Medical Devices Warning System

      Regulation on Sales, Advertisement and Promotion of Medical Devices

      Medical Device Clinical Research Regulation

      Regulation on Testing, Control and Calibration of Medical Devices

ISO 13485 Medical Devices Quality Management System

The ISO 13485 Medical Devices Quality Management System standard was published by the International Standards Organization Technical Committee in 2003. The ISO 13485 standard, which specifies the minimum requirements of medical device manufacturers, is actually based on the ISO 9001 standard. The structures of both standards are the same. Many conditions are parallel. In addition, some sector-specific features have been taken exactly in the ISO 9001 standard and only sector-specific additions have been made. In addition, the direct ISO 13485 standard also includes a number of conditions specifically designed for medical devices.

Medical device manufacturers who want to provide free circulation of medical devices manufactured in our country and sent abroad in European Union countries and all over the world are required to establish ISO 13485 Medical Devices Quality Management System in their enterprises.

The ISO 13485 standard was born in the European Union, but it has become a recognized standard in any country in the world. This standard is applicable to all companies that design, manufacture, assemble and install medical devices and provide technical support services after installation.

ISO 13485 Certificate What Companies Gain

Companies that want to comply with European Union harmonization laws and other legal regulations in medical device manufacturing and technical support activities establish and implement ISO 13485 Medical Devices Quality Management System in their enterprises. Naturally, they apply to a certification body in order to prove their status and if they pass the audits, they obtain ISO 13485 Certificate. There is no requirement for companies to obtain ISO 13485 Certificate. Regardless of their size, production capacity and number of employees, companies producing medical devices within the scope of the Medical Device Regulation published by the Ministry of Health in 2007 can establish ISO 13485 Medical Devices Quality Management System and obtain ISO 13485 Certificate.

These companies have obtained ISO 13485 Certificate and are making significant gains. For example,

      Quality is improved in the design, production and service activities of medical devices

      Quality awareness is increased in company employees

      Increased product and service quality gives importance to human health

      Standardization of production and service activities

      In this way, the firm will strengthen its hand in exports to the European Union countries

      It also ensures compliance with global markets

      A process-oriented approach is adopted in product and service delivery

      Documentation works related to production and service activities

      Gain competitive advantage in national and international markets

      The company's reputation and prestige increases in national and international markets

      Increased customer confidence in manufactured medical devices

      Compliance with relevant regulations

      Ensures the efficiency and continuity of the existing system

Why ISO 13485 Certificate is required

Companies producing medical devices receive ISO 13485 Certificate for the following purposes:

      Fulfill the requirements of current legal requirements

      To meet the needs and expectations of customers

      Improving in-house productivity

      To create a legal guarantee against possible lawsuits

In addition, companies that have to put CE marking on their products must obtain ISO 13485 Certificate if they have to use Annex I and Annex II modules. In other words, if the production quality assurance module is selected within the scope of CE marking, companies have to establish ISO 13485 standard.

The CE marking means compliance with the European Union and other countries that have accepted the legal regulations of the European Union. The directives issued by the European Union aim to ensure that many products comply with the European Union directives and standards in terms of health and safety. Thus, free circulation of these products is made possible.

In 1985, the European Union moved away from the classical approach and started to apply New Approach policy. Accordingly, instead of harmonizing the product standards, it was ensured that similar products were collected in a group and a general technical document was created. This new approach also includes testing and certification.

In this context, the CE Mark indicates that products covered by the New Approach Directives and Regulations comply with the relevant basic requirements and undergo the necessary procedures.

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ISO 13485 Certificate

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