Events & Seminare

Your career stepping stone into the world of medical software & apps!

Our practice-oriented course on all regulatory requirements for medical software and applications in a compact online course. The course language is ENGLISH!

5 Days from October 10 until December 17, 2025 | 9am – 4.30pm

Information & Registration for our online certificate course!

Unlock the Future of Healthcare!

On November 6th, 2025, the first round of our compact online course on all regulatory requirements for AI-based medical devices and in vitro diagnostics (IVD) devices will start. The course will be taught in English!

Gain practical insights into regulatory pathways, cutting-edge compliance strategies, and international best practices. Whether you’re a developer or regulatory professional, this course will empower you to bring innovative AI-driven solutions to market safely and efficiently. Enroll now to stay ahead in the rapidly evolving world of medical technology!

5 modules = 5 afternoons (13:30-17:30 – ONLINE)

Information & Registration for our online certificate course!

AI-driven innovation is transforming U.S. healthcare—from diagnostics to personalized medicine. But with this progress come high regulatory expectations. The FDA’s latest guidances outline clear pathways for managing AI across the product lifecycle, including how to implement algorithm changes using Predetermined Change Control Plans (PCCP).

Learn how to get a global overview of AI-related requirements in the US regulatory landscape for medical devices and IVDs. You will gain practical skills to assess technical documentation, ensuring both compliance and successful market access of AI-powered health technologies.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Regulations for AI-based Medical Devices and IVD in USA

• Overview of the most important concepts and terms in AI
• Regulations in USA
  • FDA Guidance on AI-Enabled Medical Devices
  • ISO 13485 – Quality management systems for medical devicessystems — Requirements for regulatory purposes
  • IEC 62304 – Software life cycle processes for medical device software
• Exercise:
  • The participants receive a fictitious AI product and work out which FDA requirements must be met. They create a checklist of the necessary documents (e.g. risk assessment, validation data, Predetermined Change Control Plan).

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

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

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

This seminar will be held in English.

Medical device software (stand alone, mobile medical apps, web applications) or software that is integrated into medical devices (firmware, embedded software) must be designed to ensure reliability and performance in accordance with its intended use. According to the EU MDR / IVDR regulations, risks must be eliminated or minimized as far as possible without worsening the risk-benefit ratio.

The establishment of an interactive risk management process over the product life cycle is indispensable for every manufacturer of medical devices. It is important to observe legal requirements and applicable standards. Especially for medical device software, additional requirements are imposed, e.g., effects of software errors, negative interactions, aspects of the IT environment and IT security, safety-relevant functions. The overall risk assessment in the context of the verification and validation steps poses major challenges for manufacturers of medical device software.

In this seminar, you will learn the basic requirements for risk analysis for medical software according to the applicable standards, be able to perform a risk analysis and document the results properly. You will be able to evaluate risks in your software and create a risk management report based on this.

Participants:

This basic course is also suitable for participants with no or little previous knowledge. For industry career changers and start-ups, this course offers an optimal introduction to the topic of risk management for medical device software.

This basic course is part of our online course: Medical Software Specialist!

Seminar contents:

• Risk management basics, definitions of terms
• Risk management process and ISO 14971
• Risk Management Analysis, Documentation Requirements
• Risk analyses for software (Scenario Based Risk Analysis, software architecture, root-cause analyses, FTA, FMEA, third-party components, concepts of IEC/TR 80002-1)
• Risk assessment and risk management report
• Production and post-production activities, (configuration management, deployment, updates of databases, operating systems, etc.)
• Change management and risk
• Normative requirements (EN ISO 14971:2019/A11:2021, references of ISO/TR 24971 and IEC/TR 80002-1:2009 ,… etc.)

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

• early bird (until 4 weeks before the seminar): Euro 540,- (excl. VAT)
• standard (starting 4 weeks before the seminar): Euro 610,- (excl. USt.)
• Incl. seminar documents as PDF and a certificate of participation
• Overview of all discounts

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

Unlock the future of healthcare: Artificial Intelligence is transforming diagnostics, robotics, and personalized medicine—but innovation brings new risks. Join our exclusive seminar to discover cutting-edge strategies for navigating the unique challenges of risk management in AI-powered medical devices and IVDs. Ensure regulatory compliance, protect patients, and lead your organization confidently into the next era of medical device software technology.

By the end of this seminar, you will have gained an overview of the global requirements for risk management of AI-related medical devices and IVDs. You will also develop practical skills in risk assessment and mitigation, ensuring compliance and successful market access for AI-powered health technologies.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Riskmanagement for AI-based Medical Devices and IVD

• Risk management basics, definitions of terms
• Risk classification according to EU AI Act and MDR/IVDR
• Relevant standards:
  • ISO 14971 (general risk management),
  • AAMI/BSI TR 34971 (AI-specific risks),
  • IEC 62304 (Riskmanagement in the software life cycle)
• Special requirements and challenges:
  • Data management: selection, anonymization, quality and representativeness of training data, validation and verification of AI models (e.g. robustness, generalizability),
  • Dealing with adaptive and learning systems (continuous learning),
  • Human oversight: mechanisms for human control and intervention options
• Exercise:
  • Create a risk matrix for an AI diagnostic tool: Participants analyze a fictitious AI-based diagnostic system, identify possible risks (e.g. incorrect classification, data bias) and evaluate these together in a risk matrix.

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

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

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

Sicherheit ist bei Medizinprodukten oberstes Ziel. Die systematische Analyse und nachweisbare Reduzierung von Risiken ist daher fixer Bestandteil gesetzlicher und normativer Anforderungen.

In diesem Seminar lernen Sie anhand eines umfassenden Übungsbeispiels, wie Sie die Anforderungen an das Risikomanagement nach der ISO 14971:2019 in Ihrem Unternehmen schnell & einfach umsetzen können.

Seminarinhalte

• Forderungen der EU-Verordnungen (MDR / IVDR) und der Qualitätsmanagement-Normen zum Risikomanagement
• Risikomanagement nach ISO 14971:2019
• Durchführung und Dokumentation des Risikomanagements mit der en.co.tec Toolbox:
  – Risikomanagementplan
  – Risikomanagementakte
  – Risikomanagementbericht
• Übungsbeispiel Risikomanagement-Akte

TeilnehmerInnen

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 das Risikomanagement von Medizinprodukten und In-vitro Diagnostika.

Ihr Trainer

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

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 540,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 610,- (exkl. USt.)
• inkl. Seminarunterlagen als PDF und ein Teilnahmezertifikat.
• alle Rabatte im Überblick

Veranstaltungsort: ONLINE

Sie benötigen für unsere ONLINE-Seminare nur einen Laptop mit Kamera und Mikrofon. Unsere eLearning-Plattform funktioniert auf allen Betriebssystemen im Webbrowser. 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.

Hier klicken für Ihre Online-Anmeldung!

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

Dieses Seminar findet an 2 Vormittagen statt!

Beim Labelling eines Produkts gilt es alle gesetzlichen Anforderungen zu berücksichtigen: Verpackung (z.B. Etiketten), Gerät (z.B. Symbole, Beschriftungen), Anweisungen (z.B. Gebrauchsanweisung) und beiliegendes Material (wie z.B. Broschüren) müssen alle Regelungen erfüllen.

Neben diesen Labelling-Anforderungen gelten die EU-Verordnungen für Medizinprodukte und IVD. Mit diesen Verordnungen ist auch in der EU die Einführung und Umsetzung der eindeutigen Kennzeichnung (UDI Unique Device Identification) von Medizinprodukten verpflichtend.

Um Ihnen Informationen aus erster Hand anbieten zu können, veranstalten wir dieses Seminar in Kooperation mit GS1 Austria, offizielle UDI-Zuteilungsstelle in Europa.

TeilnehmerInnen

Basiskenntnisse zur MDR bzw. IVDR sind empfehlenswert.

Die Seminar-Inhalte

• MDR – Anforderungen an UDI:
  – Überblick UDI
  – Schnittstellen UDI (Qualitätsmanagement, Produktion, andere Geschäftsprozesse)
  – UDI als Teil von EUDAMED
• Labelling – Anforderungen an Verpackung, Gerät, Anweisungen und beiliegendem Material
  – ISO 15223-1:2017 Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen
  – EN ISO 20417:2021 Medizinprodukte – Anforderungen an vom Hersteller bereitzustellende Informationen
  – Sprachanforderungen an das Labelling
• Schritte zur erfolgreichen Umsetzung von UDI
  – UDI Vergaberegeln
  – UDI Kennzeichnungsregeln
  – Strichcodequalität
  – Strichcodeprüfung
  – Stammdatenverwaltung
  – Stammdatenaustausch

Dieses Seminar ist Teil unseres Online-Lehrgangs: Regulatory Specialist für Medizinprodukte und IVD.

Termine

Dieses Seminar findet an 2 Vormittagen statt:

• 26.11.2025, 09:00-12:00 Uhr mit Frau Poppy Abeto Kiesse, MSc und
• 05.12.2025, 09:00-12:30 Uhr mit beiden Trainern

Ihre TrainerInnen

• DI Martin Schmid, Geschäftsführer & Senior Consultant bei en.co.tec Schmid KG
• Poppy Abeto Kiesse, MSc., Business Development Manager Healthcare bei GS 1 Austria GmbH

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 540,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 610,- (exkl. USt.)
• inkl. Seminarunterlagen als PDF und Teilnahmezertifikat
• alle Rabatte im Überblick

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.

Hier klicken für Ihre Online-Anmeldung!

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

Information Security, Cybersecurity & Data Protection – Achieve Compliance Successfully!

Artificial intelligence (AI) has transformed the landscape of medical devices and in vitro diagnostics (IVD), ushering in new opportunities and challenges for healthcare innovation. As these technologies become increasingly integrated into critical healthcare infrastructure, it is essential for professionals to understand the evolving regulatory and cybersecurity landscape.

Not every manufacturer is necessarily considered the provider of a high-risk AI system. Many medical device manufacturers use large language models (LLMs) from different vendors for their software development. As a result, companies assume various roles and responsibilities under the Medical Device Regulation (MDR) and the AI Act.

This introductory course provides a comprehensive overview of the fundamental requirements for AI-based medical devices and IVDs, with a focus on compliance with the NIS2 Directive and ISO 27001 standards.

In this seminar, our expert expertly illustrates the interconnections between MDR, the AI Act, and the NIS2 directive. Using best practice examples – especially from ISO/IEC 27001 certification- he demonstrates actionable solutions. Data protection, as an essential aspect, is also thoroughly addressed.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

NIS2 Requirements and ISO 27001 for AI-based Medical Devices and IVD

• Requirements for information security, cybersecurity and privacy protection
• Implementation of information security management systems
• NIS 2 Directive – cybersecurity risk-management and reporting obligations
• Implementing a compliance strategy within the fields of medical devices, information security, artificial intelligence and data protection

Your Trainer

• Dr. MMag. Markus Speiser:  As a doctor of law, trained business economist, project manager, and data protection officer, I support economic actors in this very exciting environment so that they can bring medical devices to market. https://www.linkedin.com/in/markus-speiser-b362b11ba/

Costs:

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

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

In this hands-on training, you will learn how to implement user experience (UX) and usability for medical software.

This starts with the topic of user research, in order to understand who the users of the software are and in which environment the software is used. If the user has to pick up the phone again and again, even though this would only be necessary at the end, then the context has not been properly understood. This can be done with systematic UX and usability methods.

Then usage requirements are defined and, for medical devices, usage errors are passed through the interface to risk management for evaluation.

This is followed by the translation into a design solution including the risk control measures. Since human behavior is not easy to predict, the design solutions are then evaluated. This can also be done by experts, but tests with users, called usability tests, are the decisive factor.

For medical software and apps, IEC 62366-1 must be met in Europe. In the USA, an FDA guidance document entitled „Applying Human Factors and Usability Engineering to Medical Devices“ applies. Here, usability testing is required at the end of development. The corresponding telemetry data of the software can be used for market monitoring.

These activities require a good understanding of UX and usability engineering which we will provide you with in this seminar.

SEMINAR CONTENT

• Legal basis according to MDR and IVDR
• Norms and standards esp. IEC 62366-1:2015+AMD1:2020
• Integration of usability engineering into risk management
• Integration of usability engineering into development
• User Research as the basis of the Use Specification according to IEC 62366-1
• Use Scenarios, Critical Tasks and Analysis of Use Errors
• User Interface Specification and pragmatic creation of requirements for the user interface
• Formative evaluation for the improvement of prototypes
• Summative evaluation for the validation of risk control measures
• Usability Engineering File and Human Factors Engineering Report

PARTICIPANTS

This basic course is also suitable for participants with no or little previous knowledge. For industry career changers and start-ups, this course offers an optimal introduction to the topic.

This basic course is part of our online course: Medical Software Specialist!

YOUR TRAINER

Dipl. Inf. (FH) Michael Engler, Senior Consultant, Managing Director at EMPIANA GmbH

COSTS

• Early bird (until 4 weeks before the seminar): Euro 540,- (excl. VAT)
• Standard (starting 4 before the seminar): Euro 610,- (excl. VAT)
• All seminar discounts at a glance
• incl. seminar documents as PDF and a certificate of participation

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

Dieser Basiskurs deckt die wichtigsten Aspekte der klinischen Prüfung und klinischen Bewertung in Übereinstimmung mit den europäischen Medizinprodukte-Vorschriften und den geltenden Leitfäden ab.

Sie lernen, wie man klinische Daten plant, generiert, dokumentiert, analysiert und einen qualitativ hochwertigen klinischen Bewertungsbericht erstellt, der für die Regulierungsbehörden und benannten Stellen akzeptabel ist. Wir zeigen Ihnen, wie sich der Prozess in die Entwicklung eines Medizinproduktes und auch in die Post-Market-Aspekte der klinischen Evidenz einfügt.

TeilnehmerInnen

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 die klinische Bewertung und Prüfung von Medizinprodukten und In-vitro Diagnostika.

Die Seminar-Inhalte

• Regulatorische Rahmenbedingungen
  • Klinische Evidenz
  • Klinischer Benefit
  • Klinische Leistungsbewertung
• Klinische Evaluation
  • Nachweise für die Einhaltung der grundlegenden Anforderungen an Sicherheit und Leistung
  • Welche Daten benötige ich für die klinische Evaluation
  • Zusammensetzung des Klinischen Evaluationsberichts

• Was ist eine klinische Prüfung?
  • Regulatorische Rahmenbedingungen für klinische Prüfungen
  • Ethikkommission
  • BASG
  • Dokumente bei Einreichung von klin. Prüfungen
•  Klinischer Prüfplan
  • Rationale von klinischen Prüfungen
  • Studiendesign und Definition von Endpunkten

Dieses Seminar / dieser Basiskurs ist Teil unseres Online-Lehrgangs: Regulatory Specialist für Medizinprodukte und IVD.

Ihre Trainerin

Priv. Doz. Dr. Ghazaleh Gouya Lechner, Expertin für Klinische Prüfungen und Bewertungen, Gouya Insights GmbH & Co KG

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 540,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 610,- (exkl. USt.)
• Inkl. Seminarunterlagen als PDF und ein Teilnahmezertifikat.
• alle Rabatte im Überblick

Veranstaltungsort: ONLINE!

Sie benötigen für unsere ONLINE-Seminare nur einen Laptop mit Kamera und Mikrofon. Unsere eLearning-Plattform funktioniert auf allen Betriebssystemen im Webbrowser. 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.

Hier klicken für Ihre Online-Anmeldung!

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