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 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.

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: 475,00 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!

About the training

Sterilization is one of the key processes in the production of sterile medical devices. Among the different sterilization types, each has its advantages and disadvantages. Evidence of successful sterilization is important and expected when demonstrating conformity with regulatory requirements.

The workshop will address the following topics related to medical device sterilization: microorganisms and their characteristics, bioburden determination for medical devices, controlled environments, clean rooms in the production of medical devices, cleaning and sterility assurance for reprocessed medical devices, and sterile barrier systems.

Through the presentation of practical examples, the attendees will learn the details of compliance assurance and get the knowledge for competent performance of medical device sterilization.

The workshop will cover the theoretical basics and requirements through practical examples and exchange of experience.

Content

• Basic sterility – microorganisms and their characteristics, medical devices’ bioburden, controlled environments and cleanrooms, cleaning and sterility assurance processes with a sterile barrier system.
• Requirements for the sterility of medical devices according to medical device directives and regulations, ISO 17665-1, and other harmonized standards regarding the sterilization of medical devices.
• Presentation of the different sterilization types (steam, dry, gas, radiation)
• The importance of contamination control of work environments and sterilization processes in relation to ISO 13485
• Procedures for the confirmation of successful sterilization of medical devices (control, validation, sterility)
• Packaging and release of sterile medical devices
• Review of the most important sterilization methods used in the medical device industry – practical cases

Costs

• Standard: 475,00 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

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

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

Regulatory requirements for medical devices on US, European, or other global markets differ. Prior to a successful sale on the US market the medical device shall be registered (e.g. procedure acc. 510(k)), and should adhere to the quality system regulation principles outlined in acc. 21 CFR 820.

Attendees will be informed of the main regulation for medical devices on the US market, 21 CFR 820, and other related regulations for medical devices (e.g. 21 CFR 803, 806, 11). The basic principles of registration processes such as 510(k) will also be discussed using practical cases.

Content

• Presentation of the regulations and requirements for medical devices on the US market with practical cases and discussions
• Methodology and registration documentation preparation
• Presentation of the registration process, assurance of compliance for FDA inspections

Costs

• Standard: 475,00 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

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

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

Since 2022 completely new rules apply to manufacturers and other economic operators (authorized representatives, importers, distributors) who want to put their in vitro diagnostic medical devices into use and make them available on the market – the long-awaited Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices or IVDRs for short. After a five-year transition period, the IVDR has replaced the IVDD (In Vitro Diagnostic Medical Devices Directive 98/79 / EC) on 26 May 2022 and applies in all EU Member States and EFTA countries.

This means that economic operators wishing to receive the CE mark for their products or to market their products in Europe encounter a new set of requirements that are generally stricter, more demanding, more complex, and time-consuming. With the IVDR, the European Commission has created a solid, transparent, sustainable, and internationally recognized regulatory framework that will improve the clinical safety, quality and reliability of IVD medical devices and ensure fair market access for manufacturers, healthcare professionals and end-users.

At the seminar, we will present the new requirements of Regulation (EU) 2017/746 which are important for manufacturers, authorized representatives, importers and distributors of in vitro diagnostic medical devices in the European Union, and for professionals involved in quality management systems, including IVD medical devices.

Content

• Overview of Regulation (EU) 2017/746 and definitions
• Obligations of economic operators
• Classification and conformity assessment
• Safety and efficacy requirements (Annex I – GSPR)
• Requirements for technical documentation
• Unique Identification System (UDI) and EUDAMED
• Post-market surveillance and vigilance

Costs

• Standard: 295,00 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

Marjeta Tušek Jelenc is a university graduate in physics. She began her professional career as a researcher at the Medical University of Vienna, where she was involved in the development of a new magnetic resonance method. In 2017, she joined SIQ Ljubljana as a professional associate in the field of medical device certification. Since April 2021, he has been employed by the Swiss company Smart Blood Analytics Swiss SA, where they develop software for in vitro diagnostic medical devices and is responsible for their compliance with relevant legislation. She is a SIQ auditor for ISO 9001, ISO 13485 and MDR.

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.

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

About the training

The regulation (EU) 2017/745 on medical devices (MDR) also sets out obligations for economic operators such as importers and distributors. The new commitments emphasize the importance of the responsibility of economic operators for medical devices in a certain part of the life cycle, such as storage and transport.

At the workshop, we will talk about the practical fulfillment of the requirements of Regulation (EU) 2017/745 for importers and distributors.

Participants are informed about the most important changes and obligations for importers and distributors of medical devices brought by Regulation (EU) 2017/745.

Content

• Basic overview of MDR requirements for importers and distributors of medical devices (Article 13 and Article 14).
• New requirements for the translation and packaging of medical devices (Article 16).
• Quality management system as a tool to meet certain requirements (register of complaints, sampling, etc.).
• Practical fulfilment of obligations, such as traceability and registration of importers.
• Common errors and identified good practices in the distribution of medical devices.

Costs

• Standard: 295,00 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

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

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.

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

About the training

Biocompatibility of medical devices is an important characteristic of safe and compliant medical devices. The main steps for ensuring biocompatibility are specified in ISO 10993-1 standard.

Attendees will participate in a workshop on the preparation of medical device biological evaluation reports covering chemical characterization of materials, documentation preparation, and justification of testing performance or its omission (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, carcinogenicity). All these issues will be discussed through practical examples.

The workshop will cover the theoretical basics and requirements through practical examples and an exchange of experiences. Attendees may send their questions at registration prior to the workshop.

Content

• Presentation of requirements for biological safety evaluations of medical devices in medical device directives and regulations, as well as ISO 10993-1 and other relevant standards
• Review of the ISO 14971 standard in relation to biological safety – preparation of a biological evaluation report concerning biological risks
• Methodology and biological evaluation report preparation
• Summary of ISO 10993-1 with practical discussions

Costs

• Standard: 475,00 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

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

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.

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

• 07.12.2023: 09:00-15:00
• 08.12.2023: 09:00-15:00
• 15.12.2023: 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

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.

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

• 07.12.2023: 09:00-15:00
• 08.12.2023: 09:00-15:00
• 15.12.2023: 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

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

• 10.01.2024: 09:00-15:00
• 11.01.2024: 09:00-15:00
• 12.01.2024: 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!

About the training

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.

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: 475,00 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. 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.