LISAvienna Regulatory Affairs Conference for Medical Devices and In-Vitro Diagnostics

LISAvienna cordially invites you to attend the ninth Regulatory Affairs Conference for Medical Devices and In Vitro Diagnostics, taking place on October 15, 2025, in Vienna. We – en.co.tec – are happy to be part of the organization and program planning team!

Look forward to a day filled with expert presentations, interactive discussions, and practical insights into all aspects of market authorization, along with the latest updates on MDR, IVDR, and other relevant regulations. Take advantage of this opportunity to stay informed and expand your professional network.

Register now to secure your spot and join us for an unforgettable experience at a fantastic venue, Apothekertrakt, Schönbrunn Palace!

This year, the talks will be held in English. Registration for the 9th conference is now open.

What’s new?

  • The conference will be conducted in English to accommodate our growing international community.
  • A professional partnering tool will enhance strategic networking, especially for start-ups and newcomers.
  • A revised session format: 3 x 3 parallel sessions instead of 2 x 5, allowing participants to attend more discussions.
  • A small conference fee will be introduced to help cover rising costs.

What stays the same?

  • Inspiring keynote lecture.
  • Leading experts from Notified Bodies and Authorities will share their insights.
  • Peers from start-ups, SMEs, industry, consulting and academia will discuss real-world challenges and solutions.
  • Plenty of opportunities for informal networking.
  • A fantastic venue: Apothekertrakt, Schönbrunn Palace, conveniently located next to subway line U4 (Schönbrunn station).

What are the costs?

  • EARLY Bird – Regular Ticket (until 8.8.2025): EUR 255 excl. 20% VAT
  • EARLY Bird – Startups* and academia (until 8.8.2025): EUR 195 excl. 20% VAT
  • Regular Ticket: EUR 295 excl. 20% VAT
  • Startups* and academia: EUR 235 excl. 20% VAT (* max. 6 years old at registration)

5 + 1 offer

Your company plans to send a larger team to the conference? When you purchase 5 tickets, LISAvienna will provide your organization with 1 additional ticket free of charge. If you’re interested, please contact Eva Schlintl directly at schlintl@lisavienna.at.

Registration: https://www.b2match.com/e/lisavienna-reg25

 

MDR Table: Klinische Daten & Post-Market Surveillance im Fokus

Der steirische Humantechnologie-Cluster lädt zur ersten Ausgabe des MDR Tables im heurigen Jahr – diesmal zusammen mit unserem Geschäftsführer und Experten Martin Schmid (en.co.tec) und Raymond Nistor (Platomics, QMD Services).

Raymond Nistor ist Mediziner, war viele Jahre in leitender Funktion für die Industrie tätig und maßgeblich am Aufbau der österreichischen Benannte Stelle QMD Services beteiligt, wo er den klinischen Bereich verantwortet hat. Zusammen mit Martin Schmid als österreichweit führenden regulatorischen Experten wollen wir unseren Fokus diesmal auf die Bedeutung klinischer Daten richten – von der Entwicklung, Zulassung bis zur Überwachung von Medizinprodukten nach ihrem Inverkehrbringen.

Wir freuen uns auf einen regen Austausch!

Für Verköstigung wird im Rahmen der Veranstaltung gesorgt.

Veranstaltungsort:

Medical Science City Graz
Campus Platz
Meetingraum 87 im Erdgeschoss – oberhalb Cafe Mensa Graz

Veranstalter:

Human.technology Styria GmbH

JETZT ANMELDEN!

SIQ: Online training course: EN ISO 13485:2016 – Quality Management System for the Medical Devices Industry – Basics

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

According to the legislation, the manufacturer of medical devices must establish a quality management system. The harmonised standard EN ISO 13485:2016, providing requirements specific to this field, has been established for that purpose.

Aim

  • Participants will learn about the basic requirements of the standard for a quality management system. The focus is on learning the scope and aim of the standard and the basic requirements that a manufacturer must meet.
  • With the knowledge gained, participants will be able to follow more advanced topics such as internal auditor activities, risk management processes, software lifecycle management, and other topics related to medical device manufacturing.

Content

  • Brief description of medical directive requirements and regulatory requirements
  • Overview of the structure of the standard
  • Overview of the scope and aim of the standard
  • Overview of the basic requirements of the standard
  • Overview of possible implementation methods (depending on the role of the organisation in the product manufacturing process)

Target group

  • Anyone who wants to learn the basic requirements for a quality management system:
  • Medical device manufacturers.
  • Component manufacturers/service providers in medical device manufacturing processes.
  • Medical software agents/suppliers.
  • Management representatives.

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 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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

For questions please text: office@encotec.at or call +43 1 8863491

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

 

SIQ: Online workshop: Cybers security of Software in Healthcare and Medical Devices – the Role of the IEC 81001-5-1 Standard

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

Cyber threats in healthcare are rising. Are your medical devices secure?

As cyberattacks threaten patient data and disrupt care delivery, the importance of cybersecurity in medical devices is paramount. The Medical Device Regulations (MDR) 2017/745/EU and 2017/746/EU, along with the upcoming EU Cyber Resilience Act, underscore this responsibility for manufacturers like yourselves. Protecting sensitive patient data, patient safety and software from these evolving threats is crucial.

How to ensure the cybersecurity of a product?

The seminar covers managing cyber risks in medical devices throughout their lifecycle. Learn about key guidelines and a new standard that defines activities for each phase, from concept to maintenance, ensuring cybersecurity and resilience against cyberattacks. Following this framework helps manufacturers develop secure devices and protect patient data. The standard (IEC 81001-5-1) becomes mandatory under EU regulations by mid-2024.

Gain Expertise in Securing Medical Software and Devices

This course equips you with the knowledge and skills to navigate the critical landscape of cybersecurity for healthcare software and medical devices.

  • Understand the growing threats of cyberattacks on patient data and healthcare systems.
  • Learn best practices for secure software development and deployment in the medical field.
  • Address current challenges and emerging trends in medical device cybersecurity.
  • Master the IEC 81001-5-1 standard for identifying and managing security risks in medical software.
  • Implement security measures throughout the entire software development lifecycle, from planning to post-market maintenance.

This course empowers you to contribute to the development and management of secure medical software and devices, ultimately safeguarding patient safety and improving healthcare outcomes.

Deep Dive into IEC 81001-5-1 for Secure Medical Software

This comprehensive course explores the critical aspects of securing medical software and devices.

  • Demystify Regulatory Requirements: Gain a clear understanding of relevant regulations and standards, with a focus on IEC 81001-5-1.
  • Implement Security Throughout the Lifecycle: Learn how to integrate the IEC 81001-5-1 requirements seamlessly into each phase of your product development cycle, from initial concept to post-market support. This covers product specifications, architecture, development, testing, market release, and ongoing maintenance.
  • Master Threat Modeling: Explore the STRIDE methodology for effective threat modeling, allowing you to proactively identify and mitigate security risks in your medical software.
  • Quality Management Integration: Discover how to seamlessly integrate medical software management processes into your existing quality management system, ensuring consistent and controlled development practices.
  • Compliance Made Easy: Understand how to demonstrate compliance with the IEC 81001-5-1 standard and identify the required documentation to streamline the process.

By taking this course, you’ll gain the knowledge and skills to develop and manage secure medical software that prioritizes patient safety and adheres to the highest security standards.

Recommended for

  • Software developers and engineers
  • Healthcare IT professionals
  • Quality assurance specialists
  • Healthcare and medical software project managers
  • Healthcare and medical software manufacturers
  • Representatives or suppliers of medical software
  • Those responsible for the quality and compliance of medical devices
  • IT staff responsible for maintaining networks in which medical devices operate
  • IT network maintainers in healthcare facilities or in networks where medical devices operate
  • Risk managers

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

Aljaž Podboršek has extensive knowledge in the field of medical devices, which he has acquired over the past 20 years. His expertise encompasses both the development of medical devices and the legislation that governs them. He has also gained experience in the establishment of various quality management systems. During his time at a medical device manufacturer, Aljaž successfully integrated quality management systems into the company’s operations. He also played an active role in the development, production, and compliance of medical devices with regulations and quality management systems in various markets. Currently, Aljaž holds the position of quality manager at a medical device manufacturer. He is also an auditor of quality management systems and technical files for medical devices at SIQ, a Slovenian company that provides certification and training services.

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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

For questions please text: office@encotec.at or call +43 1 8863491

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

 

Online-Forum Roundtable: Regulatory Update für Medizinprodukte & In-vitro Diagnostika

Aktuelles und Best Practice aus den Bereichen

Regulatory Affairs und Qualitätsmanagement

für Medizinprodukte und IVD

 

Gemeinsam mit den Clusterorganisationen Standortagentur Tirol, LISAvienna, Human.technology Styria, Medizintechnik-Cluster Oberösterreich, ecoplus Niederösterreich und Innovation Salzburg erweitern wir wieder die regionalen „MDR Stammtische“ zu einem österreichweiten Online-Forum Roundtable.

In dieser Cross-Cluster-Veranstaltung wollen wir Ihnen wieder ein Regulatory Update zu speziellen Themen der MDR-IVDR geben.

Neben den Expertenvorträgen und Praxis-Beispielen gibt es daran anschließend wieder die Möglichkeit für individuelle Fragen!

Programm

  • 09:00 Updates aus den Bundesländern
    Life Science Cluster Austria
  • 09:15 Regulatory Update: Was uns 2025 erwartet?
    Martin Schmid, Geschäftsführer, en.co.tec
  • 09:35 Update DIGA Erstattungsprozess Österreich & Status MDR-IVDR
    Philipp Lindinger, Geschäftsführer, AUSTROMED
  • 09:55 Research Use Only Produkte im rechtlichen Kontext
    Ruth Mahfoozpour, Head of Legal, Platomics GmbH
  • 10:15 Best Practice – Insights
    Birgit Sebauer, Head of Quality and Regulatory Affairs, HARPS Europe Manufacturing GmbH
  • 10:30 Q & A

Veranstaltungsort: ONLINE

Das Online-Forum ist kostenlos.

Hier geht’s zur Anmeldung

Basic Course: Clinical evaluation for medical software

This course provides you with in-depth knowledge of the clinical evaluation of medical software in accordance with the requirements of the European Medical Device Regulation (MDR) and the associated guidelines.

You will learn how to plan, collect, document and analyze clinical data specifically for medical software. Also you will learn how to create a high-quality clinical evaluation report for regulatory purposes.

The course highlights the special features of software development in the context of clinical evaluation and shows how this fits into product development and post-market surveillance.

Participants

This course is aimed at developers, quality managers, regulatory affairs specialists and other professionals working in the field of medical software.

Seminar contents

  •  Regulatory requirements for medical software
    • Classification of software as a medical device
    • Clinical evidence and clinical performance of software
    • Special requirements of the MDR for software products
  • Clinical evaluation for medical software

    • Regulatory framework for software studies
    • Design of studies for algorithms and AI-based products
    • Involvement of ethics committees and authorities
  • Integration into the product life cycle
    • Role of clinical evaluation in software development
    • Post-market surveillance and continuous evidence generation
    • Handling updates and changes to software

Costs

  • Early bird (until 4 weeks before seminar): Euro 260,- (excl. VAT)
  • Standard (starting 4 weeks before the seminar): Euro 305,- (excl. VAT)
  • incl. seminar documents as PDF and a certificate of participation
  • All seminar discounts at a glance

Your Trainers from Gouya Insights GmbH & Co KG

  • Priv. Doz. Dr. Ghazaleh Gouya Lechner | expert in clinical trials and assessments
  • Sandra Scheidl, Msc. | Director clinical program

Location: ONLINE

You only need a laptop with camera and microphone for our ONLINE seminars. Our eLearning platform works on all operating systems in the web browser. You will receive the seminar documents and the link to the virtual seminar room in time by email. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.

Click here to book now!

For questions: office@encotec.at or +43 1 8863491

SIQ: Online workshop: Compliance of Medical Device Software (EN 62304)

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: 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 PhD 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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

For questions please text: office@encotec.at or call +43 1 8863491

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

 

SIQ: Online workshop: European Medical Device Regulation (EU) 2017/745 (MDR)

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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

For questions please text: office@encotec.at or call +43 1 8863491

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

 

SIQ: Online-Workshop: Medical Devices – Guidelines for Preparing Technical Documentation (3 days)

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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

For questions please text: office@encotec.at or call +43 1 8863491

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

 

NEU! Basiskurs: Change Management für Medizinprodukte

Regulatorische Anforderungen, neue Technologien, neue Märkte und ein wachsender Wettbewerbsdruck erhöhen die Schlagzahl der notwendigen Änderungen und erfordern eine hohe Anpassungsfähigkeit. Um in diesem dynamischen Umfeld negative Auswirkungen auf die Einhaltung regulatorischer Anforderungen zu vermeiden, bedarf es eines robusten Change Managements.

In diesem Seminar möchten wir uns eingehend mit dem Change Management in diesem spezifischen Kontext beschäftigen.

Wir werden die Grundlagen des Change Managements beleuchten, seine Bedeutung für das Qualitätsmanagement in der Medizinprodukteindustrie herausarbeiten und konkrete Methoden zur Planung und Durchführung von Veränderungsprozessen entwickeln.

Dabei werden wir auch auf die besonderen Herausforderungen eingehen, die sich aus der strengen Regulierung dieser Branche ergeben. Mit vielen Praxis-Beispielen!

Seminarinhalte

  • Grundlagen & Methoden des Change Managements
  • Bedeutung von Change Management im Qualitätsmanagement für Medizinprodukte
  • Planung & Durchführung von Veränderungsprozessen
  • Fall-Beispiele & Diskussion

Termin

04.02.2025 von 10:00 bis 15:00 Uhr

Teilnehmer:innen

Dieses Seminar ist für Teilnehmer:innen ohne Vorkenntnisse geeignet. Qualitätsmanagement-Erfahrung ist aber von Vorteil!

Das Seminar bietet eine umfassende Einführung in das Change Management mit besonderem Fokus auf die Bedürfnisse der Medizinprodukteindustrie. Es ist ideal für alle, die sich mit den Herausforderungen des Wandels in dieser Branche auseinandersetzen und lernen möchten, wie sie Veränderungsprozesse erfolgreich gestalten können.

Ihr Trainer

DI Martin Schmid, Geschäftsführer & Senior-Consultant, en.co.tec Schmid KG

Kosten

Anmeldung

First-come, first-served! Begrenzte Teilnehmerzahl, damit ausreichend Gelegenheit für Fragen und persönliche Gespräche bleibt.

Online-Anmeldung bis 31. Jänner 2025 möglich.

Anmelde- und Stornobedingungen

Veranstaltungsort:

Standortagentur Tirol GmbH
Ing.-Etzel-Straße 17, 2. OG
A-6020 Innsbruck

Eine Kooperationsveranstaltung der Standortagentur Tirol und en.co.tec Schmid KG.