2 – 90/385/EEC Regulation of Active Implantable Medical Devices

Identification of the eligibility of the assessment procedures of the medical devices operating the body over 30 days and powered by a source other than gravitational force and the examination of specific requirements for body deployable medical devices are explained in this training in detail.

3 – ISO 13485:2016 Quality Management System for Medical Devices

In addition to the general quality management system requirements, quality management system requirements in terms of legislation for medical devices (cleaning requirements, sterilization, post-sale surveillance, risk management, etc.) are examined in this training in detail.

4 – Internal Auditor Training

This is a practical training that includes the training of internal auditors, who will do the auditing according to the standards of medical devices quality management system (ISO 13485) and also general management system (ISO 9001, ISO 14001, etc.) and examination of internal audit process according to the ISO 19011 standards.

5 – 2017/745/EU Medical Device Regulation (MDR)

On May 5^th 2017, EU official gazette announced the combination of 93/42/EEC and 90/385/EEC regulations and decided to repeal both regulations after May 2020.

Lots of subject placed shortly in these regulation which are deeply found in guidance documents (like after sales surveillance-clinical evaluation etc.) will be available in this new regulation.

Besides, you will find detailed clinical evaluation examinations (scrutiny), UDI (unique device identification) system, responsibilities of distributors and importers for Implants and class III devices clearly.

6 – ISO 14971:2012 Risk Management for Medical Devices

Güvenli tıbbi cihaz tasarımı ve üretimini amaçlayan tıbbi cihaz mevzuatının temeli risk yönetimidir. Tıbbi cihazın yaşam döngüsü boyunca tüm risklerinin tanımlanması, risklerin elimine edilmesi için gerekli risk kontrol önlemlerinin tanımlanması ve uygulanması, artık kalan riskler için risk/fayda analizi ile risklerin kabul edilebilirliğinin gösterilmesi bu eğitimde irdelenmektedir.

7 – MEDDEV 2.7/1 Rev.4 Clinical evaluation for medical device manufacturers and notified bodies

As a principal, sustainability of all medical devices should be shown via clinical assessment. The selection of the clinical assessment method, comparison with equivalent medical devices, identification of the best medical device (state-of-art) or best practice or comparison with such medical device, clinical demonstration of the performance (purpose of use) or safety (side-effects) statements of the medical device declared by the manufacturer, exploration of the literature review, preparation of the clinical trial process (if there is one) and clinic assessment reports are covered within the scope of this training.

8 – MEDDEV 2.12/1 Rev.8 Vigilance system for Medical Devices

Reporting unexpected results and problems to the authorities, actions needs to be taken after reporting, preparing final reports, preparing trend reports and reviews are the basic subjects of this training.

9 – Sterilization and the Validation of Sterilization 

Term of Sterilization, primary sterilization methods (EO, gamma, steam, aseptic filling), Term of Validation (IQ= Installation qualification, OQ=operational qualification, PQ= performance qualification), related standard for each methods  (ISO 11135, ISO 11137-1, -2, ISO 17665, etc.) and validation process, repeated validation process, regular sterilization and validation process, content of the reports are the main subjects of the this training.