Aktuelle Seminartermine

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

About the training

The course will present the requirements of the EN ISO 13485:2016 standard for the quality management system in the production of medical devices (and related services) and related legislation applicable to the field of medical devices.

Medical devices placed on the market must comply with the Regulation (EU) 2017/745, which applies to each individual product of a particular type or model and it has in certain areas has a significant impact on both the QMS and the devices themselves.

Intention

The basic purpose of the standards is to facilitate the harmonization of legal requirements applicable to this area. In the course you will gain knowledge that will help you in:

• establishing and / or maintaining a quality management system,
• preparation of documentation or technical files for medical devices,
• obtaining the CE certificate for medical devices,
• effective implementation of internal audits.

Content

• Review of the requirements of EN ISO 13485: 2016; Medical devices – Quality management system – Requirements for legislative purposes
• Comparison with ISO 9001 requirements, with emphasis on specific requirements for development, infrastructure and working environment, traceability, and reporting
• Risk management
• Familiarization with the requirements of the medical directive and the activities necessary to meet the requirements
• Regulation (EU) 2017/745
• Internal auditing – purpose, planning, preparation, implementation, reporting
• Case study: recording of nonconformities and simulation of assessment
• Written knowledge test

At the end of this course, participants will be able to:

• Understand the requirements of ISO 13485:2016 for medical products and related services
• Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
• Acquire the skills to take on the position of Internal Medical Services Auditor in their company

Dates

• 17.02.2025: 09:00-15:00
• 18.02.2025: 09:00-15:00
• 19.02.2025: 09:00-15:00

Costs

• Standard: 1.235,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Uroš Tacar has more than 25 years of experience in medical devices and in the field of development and legislation. He participated in the establishment of the quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of development manager and representative of the quality management. Among the most important tasks, he led the production and maintenance of technical folders of medical devices. He is a consultant and works at SIQ as a lecturer and long-term assessor in the field of medical devices.

Location: ONLINE

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

The EU legislation (MDR) in the field of medical devices stipulate that manufacturers of medical devices must label their products with CE markings before launching them on the EU market. In this way, the manufacturers state that the medical device complies with the EU regulation in the field of medical devices and guarantee a safe and professional medical device.

Intention

At the workshop, you will learn about the regulatory requirements and can find out whether your products comply with the requirements of the EU regulations for medical devices

Content

• Structure
• MDR requirements
• Requirements for manufacturers, importers, and distributors of medical devices
• MDR classification – Annex VIII
• Compliance assessement procedures – Annexes IX – XI

Costs

• Standard: 495,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Uroš Tacar has more than 28 years of experience in medical devices and in the field of development and legislation. He participated in the establishment of the quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of development manager and representative of the quality management. Among the most important tasks, he led the production and maintenance of technical folders of medical devices. He is a consultant and works at SIQ as a lecturer and long-term assessor in the field of medical devices.

Location: ONLINE

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.  Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

About the training

Regulation (EU) 2017/745 on Medical Devices (MDR) also deals with the preparation of a technical documentation to demonstrate conformity of a medical device. A technical documentation has gained in importance in the process of demonstrating compliance, and its preparation is of focal importance. The content and complexity are determined by various factors, especially the classification, intended use, type of a device, specific properties of the product, method of production, etc.

Purpose

Participants get familiar with the requirements relating to medical devices and the current legislation, as well as with the requirements for the conformity of medical devices. Based on practical examples, the participants get to know the tools for identifying the need for compliance of a device with harmonized standards, which directly affects the structure and content of the technical documentation. Based on the acquired knowledge and the consideration of practical examples, the participants prepare a short study – a draft technical documentation for a medical device.

Content

• Basic overview of MDR requirements relating to technical documentation
• Supporting documents, guidelines (MEDDEV, GHTF and similar)
• Structure of a medical device technical documentation
• Classification of medical devices
• Risk management (EN ISO 14971)
• Applicability (EN 62366)
• Biological evaluation (ISO 10993)
• Sterilization
• Clinical evaluation of a medical device
• Labelling and instructions for use of a medical device
• Construction and implementation documentation
• Declaration of conformity
• Classification of medical devices
• Use of harmonized standards and cases of incorrect application of standards
• Preparation of risk assessment documentation
• Making a clinical evaluation
• Creating a usability record
• Making a record of biological evaluation
• Preparation of model instructions for use
• Preparation of a declaration of conformity
• Frequent mistakes and identified good practices of economic operators

After the first two meetings, the participants prepare a short, focused study – a draft technical documentation for a medical device, which they present to the group in the third part of the workshop and exchange good practices.

Dates

• 13.03.2025: 09:00-15:00
• 14.03.2025: 09:00-15:00
• 21.03.2025: 09:00-15:00

Costs

• Standard: 1.195,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Matija Rupnik has been active in the field of medical devices, their development and related legislation since the beginning of his career. He has participated in the establishment of quality systems in accordance with international legislation and in ensuring the compliance of active medical devices. For manufacturers, he performed the tasks of integrating quality management systems, determining regulatory strategies, and ensuring the compliance of medical devices, including the production and maintenance of medical device technical documentation. He is currently the head of regulatory matters at one of the manufacturers and an SIQ auditor.

Location: ONLINE

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

About the training

To prove the conformity of a programmable active medical device or stand-alone software with medical directives, it is necessary to provide safe, effective, and compliant software.In the case of software as a stand-alone medical device or as part of an active medical device, the requirements of EN 62304 standard are used to demonstrate compliance, and the organization must have ISO 13485 quality management system in place.Join our workshop about the requirements of medical directives applicable to medical software and learn how to establish compliance through practical examples.

Content

• Brief description of the requirements of medical directives
• Classification of the product as a medical device
• Defining conformity requirements for the product
• Ways to demonstrate the compliance of medical software
• Descriptions of software as a medical device
• Integration of medical software management processes into the quality management system
• Demonstration of compliance with the requirements of the standards and expected documentation
• An overview of the most important points in software development from the point of view of medical directives – practical examples

Costs

• Standard: 495,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Rok Hrovatin started assessing the risk of medical devices only a few years before Slovenia’s accession to the EU. The transposition of European directives has established requirements in this area with the Medical Devices Directive (MDD 93/42 / EEC). He gained experience and knowledge as the head of the testing laboratory for medical devices at SIQ, and soon after that also as a leading auditor in the field of medical devices and as a lecturer in this field.

Location: ONLINE

The online workshop will take place in a live online e-classroom. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.