This training course aims to provide guidance on the implementation of the requirements set out in the Medical Devices Directive (MDR). It focuses on helping you prepare a clear concept or project plan and how to integrate the requirements into your business and documentation.

 You must also gain the confidence and expertise to evaluate and implement more specific requirements on your own. MDR is legislation that details the requirements that manufacturers must meet to place medical devices on the market in the European Union. MDR focuses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management considerations, post-market surveillance (PMS), transparency and traceability.

 The Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as will manufacturers of some devices that do not have a medical purpose (for example, devices used for aesthetic modification of the body or contact lenses that change eye color without correcting vision).

 The Medical devices CE marking course is designed to provide participants with information that will help their companies bring products to market quickly. You will learn about the Medical Device Directive requirements and the CE marking approach. Participants will be able to lead their organizations in bringing medical devices to market in the European Union.

 The Implementation of the In Vitro Diagnostics Directive course is designed to enable you to explore the IVD Directive, better understand the requirements and thus enable the efficient deployment of your IVD devices on the European market. You will be able to apply the requirements of the directive to create technical documentation that will support the product throughout its lifecycle.

 Designed to support manufacturers by validating current regulatory requirements of technical documentation. The aim of the course is to accelerate the Notified Body certification process and enable manufacturers to sell compatible devices within the European Union. Upon completion of the training, you will be able to identify and locate all regulatory requirements and guidance documents necessary to write procedures that enable the creation and maintenance of compliant technical and design files.

 The ISO 13485 Implementation course is designed to provide knowledge and process steps that will enable students to effectively implement a Quality Management System in line with ISO 13485 certification requirements. The course introduces the concepts needed to understand, develop and implement a quality management system.

 Demonstrate your ability to provide medical devices and related services that meet quality and regulatory demands in line with ISO 13485:2016 Medical Device requirements for Quality Management System (QMS). This course provides a clause-by-item understanding of ISO 13485:2016 and provides an effective solution to meet the comprehensive requirements of an effective QMS.

 The Technical File Writing for Compatible Devices course is designed to support manufacturers by validating current regulatory requirements for technical documentation. The aim of the course is to speed up the certification process and enable manufacturers to sell compatible devices within the European Union. Once you complete the training, you will be able to identify and locate all regulatory requirements and guidance documents necessary to write procedures that enable the creation and maintenance of compliant technical and design files.

 This course is designed to provide participants with an understanding of the impact of ISO 14971 on the decision-making process in medical device manufacturing companies. This course helps medical device professionals understand how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485. The training will include exercises and participants will have the opportunity to ask questions about ISO 14971 and how risk management is implemented in their organisation.

 Post-market surveillance, including clinical follow-up, complaint and vigilance handling, affects all aspects of the Quality Management System. Proactive and reactive sources of information are a regulatory requirement that should be included in your post-marketing surveillance procedures that apply to all products. Obtaining accurate post-marketing information will identify consumer needs to ensure ongoing compliance with directives and enable continuous product development. The Post-Market Surveillance and Vigilance course is designed to help you identify the requirements of the European Medical Device Directives, standards and guidance documents to ensure the effective implementation of a post-market surveillance system.

 The Clinical Evaluation for Medical Devices course is designed to support manufacturers by validating the information necessary to demonstrate the clinical safety and performance of their products in accordance with the requirements of the European Medical Devices Directive. Upon completion of the training, manufacturers will be able to determine whether a clinical trial is warranted, prepare a clinical evaluation report including a review of the literature, and identify post-market clinical follow-up and post-market surveillance requirements to support continued compliance.

 The Process Validation for the Medical Device Industry course is designed to help manufacturers gain awareness of the quality requirements for validation and the nature of “special processes.” Learn generally accepted principles of verification and introduce how-to methods for installation, operational and process qualification.

 Clinical Research refers to any scientific research conducted on volunteers or materials obtained from them.

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What are the Studies Conducted with Medical Devices?

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 Clinical Research of Medical Devices according to Article 4 of the Regulation on Clinical Research of Medical Devices published in the Official Gazette dated 06.09.2014 and numbered 29111; It is defined as "systematic research or studies conducted on volunteers for the purpose of evaluating the safety, effectiveness or efficiency of medical devices." “Performance of the medical device” is included in paragraph (r).

 Clinical research is carried out on all medical devices, whether they have received the CE mark or not. They are divided into two categories: academic and commercial. Clinical studies can be retrospective (retrospective) or prospective (prospective).

 A successful research begins with successful planning. Contact us for end-to-end service from the planning stage to the completion of the clinical trial.