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

What are in vitro diagnostic (IVD) medical devices?

IVD medical devices are tests used on biological samples (such as tissue, blood, or urine) to determine a person’s health. There is a very wide range of IVD medical devices, from pregnancy self-testing aids, blood glucose meters to HIV tests, blood group tests and various types of cancer tests. Unlike medical devices or IVD pharmaceuticals, medical devices never come into contact with a person and do not treat patients but provide information about the functioning of the body. IVD medical devices do not cause direct harm, but they pose a very high risk if their use leads to misdiagnosis. A detailed definition of IVD medical devices is given in Regulation (EU) 2017/746, Article 2.

The IVDR 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 obtain the CE marking for their products or to market their products in Europe have to comply with a new set of stricter, more demanding and more complex requirements with which their products must comply. With the IVDR, the European Commission aims in particular to create a robust, transparent, sustainable and internationally recognised 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.

This means that economic operators wishing to receive the CE mark for their products or to market their products in Europe will encounter a new set of requirements that are generally stricter, more demanding, more complex, and time-consuming than those currently required to comply with. With the IVDR, the European Commission wants to create 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.

Als Medizinprodukteberater*in übt man eine verantwortungsvolle Tätigkeit aus, die in Österreich gesetzlich definierte Rechte und Pflichten trägt. Diese nationalen Anforderungen bleiben weiterhin im neuen Medizinproduktegesetz (MPG) als wesentliche Bestandteile enthalten. Lt. MPG sind Hersteller oder eine von ihm beauftragte Person oder Stelle verpflichtet, MedizinprodukteberaterInnen regelmäßig zu schulen (inkl. Schulungsnachweis).

In diesem Basiskurs vertiefen Sie Ihre Kenntnisse in den wesentlichen national und international gültigen Rechtsgrundlagen und erfahren, wie Sie die Anforderungen schnell & praxisorientiert umsetzen können!

Die Seminar-Inhalte

• Medizinproduktegesetz (MPG)
• Anforderungen an Medizinprodukteberater*innen
• EU-Verordnung (MDR+IVDR)
• CE-Kennzeichnung
• Klassifizierung von Medizinprodukten
• Rechtliche Aspekte zu Marketing & Sales
• Begriffsbestimmungen und Qualitätskriterien
• Fallbeispiele

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 520,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 590,- (exkl. USt.)
• inkl. Seminarunterlagen als PDF und Teilnahmezertifikat
• alle Rabatte im Überblick

Ihr Trainer

• DI (FH) Dr. Andreas Böhler, MLBT, Geschäftsführer R’n’B Consulting GmbH und langjährige Erfahrung in der Beratung und Schulung für regulatorische Themen für Medizinprodukte und IVD

Veranstaltungsort: ONLINE

Sie benötigen für unsere ONLINE-Seminare nur einen Laptop mit Kamera und Mikrofon. Unsere eLearning-Plattform funktioniert auf allen Betriebssystemen im Webbrowser (zB Firefox, Safari oder Chrome). Die Seminar-Unterlagen und den Link zum virtuellen Seminarraum erhalten Sie rechtzeitig per Email. Das Seminar wird interaktiv – ähnlich einem Präsenz-Seminar – gestaltet: dh Sie können Ihre Fragen an den Vortragenden stellen, es wird Übungsbeispiele geben und auch die Möglichkeit, sich mit den anderen TeilnehmerInnen auszutauschen.

Jetzt buchen!

Hier geht’s zur Online-Anmeldung.

Bei Fragen: office@encotec.at oder +43 1 8863491

Um Medizinprodukte auf den Markt bringen zu können, gibt die EU-Verordnung für Medizinprodukte / Medical Device Regulation (MDR) einen klaren, aber doch sehr komplexen Weg vor.

In unserem MDR-Basiskurs lernen Sie Schritt für Schritt, welche Anforderungen Sie berücksichtigen müssen, damit Sie Ihre Medizinprodukte lt. MDR auf den Markt bringen können. Die einzelnen Schritte werden übersichtlich und mit vielen Praxis-Beispielen erklärt.

Teilnehmer*innen

Dieser Basiskurs ist auch für TeilnehmerInnen ohne Vorkenntnisse oder mit geringen Vorkenntnissen geeignet, für Branchen-Quereinsteiger und Start-Ups bietet dieser Kurs einen optimalen Einstieg in die gesetzlichen Rahmenbedingungen für Medizinprodukte.

Die Seminar-Inhalte

• MEDIZINPRODUKT-Einführung
  Der Weg zur CE-Kennzeichnung
• START-PHASE
  Zweckbestimmung, Rechtliche Regelung / Richtlinien, Klassifizierung, Konformitätsbewertungsverfahren, Verantwortliche Person (PRRC)
• ENTWICKLUNGSPHASE
  Technische Dokumentation, Grundlegende Anforderungen, Harmonisierende Normen, UDI, EUDAMED, Klinische Bewertung / Klinische Prüfung
• RELEASE-PHASE
  EU-Konformitätserklärung, CE-Marking, Registrierung im Medizinprodukte-Register, Medizinprodukte-Betreiber-Verordnung
• POST-MARKET-PHASE
  Post Market Surveillance, Vigilanz, Post Market Clinical Follow-up, Änderung MP

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 520,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 590,- (exkl. USt.)
• inkl. Seminarunterlagen als PDF und Teilnahmezertifikat
• alle Rabatte im Überblick

Ihr Trainer

Daniel Rubisoier, BSc, MSc, Conformity Assessement Procedure Specialist MDR, TÜV SÜD Product Service GmbH

Veranstaltungsort: ONLINE

Sie benötigen für unsere ONLINE-Seminare nur einen Laptop mit Kamera und Mikrofon. Unsere eLearning-Plattform funktioniert auf allen Betriebssystemen im Webbrowser (zB Firefox, Safari oder Chrome). Die Seminar-Unterlagen und den Link zum virtuellen Seminarraum erhalten Sie rechtzeitig per Email. Das Seminar wird interaktiv – ähnlich einem Präsenz-Seminar – gestaltet: dh Sie können Ihre Fragen an den Vortragenden stellen, es wird Übungsbeispiele geben und auch die Möglichkeit, sich mit den anderen TeilnehmerInnen auszutauschen.

Jetzt buchen!

Hier geht’s zur Online-Anmeldung.

Bei Fragen: office@encotec.at oder +43 1 8863491

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

About the training

This training course will present the requirements of the new Regulation (EU) 2017/745 on Medical Devices, focusing on the regulatory requirements for manufacturers and other business entities after placing medical devices on the market. We will discuss all post-market monitoring activities and learn about the requirements for ensuring the traceability of medical devices. The main purpose of the new requirements of the Regulation is to ensure that only safe and effective medical devices are used in the Common European Market and beyond.

Content

• Overview of the basic differences between the MDD and the MDR in the area of traceability
• New requirements for medical device manufacturers
• New developments in the area of requirements for medical devices
• Explanation of the regulatory requirements for participating legal entities
• Ensuring the traceability of medical devices and their labelling
• Post-market monitoring and reporting obligations

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. 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 safety of medical devices is largely based on the processes by which these devices are manufactured. It is therefore essential to be able to identify and manage the risks associated with these processes, as required by the latest edition of EN ISO 13485:2016. It sounds simple, but the following questions soon arise:

• What is a process risk anyway?
• Which processes need to be addressed from a risk perspective and when?
• What is the basis for risk treatment and how is it carried out?
• How much does experience count in product risk assessment – is the methodology transferable?
• Which guidelines (standards) can be relied opon?
• How to maintain effective process risk management in medical device manufacturing?

Content

• Documents – the origin of the requirement and basic concepts
• Standards and editions addressing process risk management, types of risks
• Requirements for manufacturers – direct and indirect
• Guidance for risk-based QMS
• Introduction of the Risk-Based Approach
• Product and process risks
• ISO 31000 – basic guidance; additions required for medical devices
• Activities of the organization when introducing the Risk-Based Approach (RBA)
• Definition of a process and procedures
• Records and examples
• Comparison with risk management requirements for medical devices

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

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.

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

About the training

This training course will present the requirements of ISO 13485:2016 standard (EN) for a quality management system in the manufacture of medical devices (and related services) and the medical device legislation supported by this standard. From this legislation (Regulation EU 2017/745 on Medical Devices), we will address the requirements for the business entities that can be involved in placing medical devices on the market.

The current legislation and the standard require a high level of documentation in this process, and we will look at both the rules for this documentation and the resulting records.

The fundamental aim of the standard and the legislation is to ensure that only safe and effective medical devices are used in the Common European Market and beyond.

This training course will provide you with the knowledge that will help you be aware of your role as a business entity, establish and/or maintain a relevant quality management system, prepare documentation or technical files for medical devices, and master the requirements for relevant records.

Content

• Overview of the requirements of (EN) ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purpose
• Explanation of the regulatory requirements for participating legal entities
• Explanation of the requirements of the standard for management system documentation
• Methods for controlling quality management system documentation
• General on the preparation of technical documentation
• Records as evidence of the implementation of the requirements of the standard and legislation

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 with medical devices and the field of development and legislation. He participated in the establishment of a quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of head of development and representative of quality management. Among the more important tasks, he managed the production and maintenance of technical files of medical devices. He currently works as an assessor at SIQ and a consultant 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.