Although medical equipment sector is a new branch of industry in our country, it shows rapid development. Our country ranks 18 in Europe and 38 in the world in the export of medical devices. The medical devices sector covers a wide range of products and technologies. Besides the diagnosis and treatment of diseases, the medical equipment sector, which has a significant importance in improving the quality of life of the patients, has a very dynamic structure and is one of the fastest developing sectors in the world.
Increasing quality of life standards, increasing the average life expectancy of people, increasing social welfare and continuing migration from rural to urban areas are important factors in this sector's growth in our country. The production and marketing of medical device products in our country is regulated by the Ministry of Health.
The importance of medical devices in the diagnosis and treatment of diseases, especially in hospitals, is indisputable. Hospitals are increasingly becoming technology-intensive enterprises.
It is not easy to answer the question of what is a medical device. This is because the variety of medical device types and their sub-groups is vast. It can be said that there are around ten thousand types of medical devices worldwide on the basis of main categories. If different versions and models of these devices are also taken into account, this number can reach up to one million.
Medical Devices Regulation published in 2007 defines medical devices as follows: When used by humans, they are devices which do not fulfill their primary function with pharmacological, immunological or metabolic effects, but which can be supported by these effects.
The pharmacological effect is the effect of drugs on living organisms. The immunological effect is related to the immune systems of living things. Metabolic effect in living organisms It is related to chemical reactions that occur during the maintenance of life.
T within the scope of the said regulationMedical devices include:
- Medical devices used to diagnose a disease, monitor its course, treat the disease or reduce its effects
- Medical devices used to diagnose, monitor, treat, reduce the effects of, and eliminate grievances in the event of an injury and injury
- Other medical devices used to investigate or alter any anatomical or physiological function in humans
- Medical devices for contraception or medication only
ISO 13485 Medical Devices Management System is designed for businesses producing medical devices. It is very important that these enterprises establish and implement this standard in a sustainable manner.
Scope of Medical Devices Management System Trainings
The ISO 13485 standard is a standard applicable to all businesses that provide design, manufacturing, installation and installation work for medical devices and provide technical support services after installation. Today it has become a sought-after standard not only for the European Union countries, but for all over the world.
our organization TÜRCERT Technical Control and Certification Inc.provides training services as well as certification studies to companies who want to establish and implement this standard in their enterprises. The training programs organized for this purpose are as follows:
- ISO 13485 Basic Requirements Training
- ISO 13485 Practice Training
- ISO 13485 Internal Auditor Training
- ISO 14971 Risk Management Training in Medical Devices
ISO 13485 Medical Devices Management System Basic Requirements Training topics are as follows:
- Explanation of all clauses of ISO 13485 standard
- Top management's role in the implementation of ISO 13485 standard
- Proper use of ISO / TR 14969 standard
- Explanation of Good Practice Processes
- Preparation for audit
- Relationship between ISO 13485 and ISO 14971 standard
- Relationship between Risk Management and ISO 14971 standard
- Risk Management and objectives
- Case studies
These trainings are usually completed in two days and successful participants receive certificates.
Our company TÜRCERT Technical Control and Certification Inc., ISO 13485 Medical Devices Management System trainings to companies with all managers and employees and strong infrastructure.