Martin Schmid (en.co.tec Geschäftsführer und Trainer) und Christa Bachinger-Hauk (en.co.tec Akademie-Leiterin) geben einen Überblick zu den Inhalten und zum Ablauf unserer Lehrgänge und beantworten gerne Ihre Fragen!
Hier gibt’s die Detail-Infos zu unseren Lehrgängen: en•co•tec – Ausbildungen
– Online-Certificate-Course: Medical Software Specialist or
– Online-Certificate-Course: Specialist for AI-based Medical Devices and IVD
Martin Schmid (en.co.tec Managing Director and Trainer) and Christa Bachinger-Hauk (Head of the en.co.tec Academy) will provide an overview of the content and structure of our course and will be happy to answer any questions you may have!
Here you can find detailed information about our courses: en•co•tec – Online-Courses
Martin Schmid (en.co.tec Geschäftsführer und Trainer) und Christa Bachinger-Hauk (en.co.tec Akademie-Leiterin) geben einen Überblick zu den Inhalten und zum Ablauf unseres Lehrgangs und beantworten gerne Ihre Fragen!
Hier gibt’s die Detail-Infos zu unseren Lehrgängen: en•co•tec – Ausbildungen
Stay compliant. Stay in control – beyond market launch. AI doesn’t stop evolving after approval – and neither should your regulatory strategy. This compact seminar gives you the essential tools to manage Post-Market Surveillance (PMS) and Change Management for AI-based medical devices and IVDs under EU MDR/IVDR and the upcoming EU AI Act.
Learn how to monitor real-world performance, manage AI model changes (including re-training and change notifications), and fulfill your reporting obligations. Gain clarity on your interactions with notified bodies and regulatory authorities – and ensure your AI-powered products remain safe, effective, and market-ready.
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.
Post-Market Surveillance and Change Management for AI-based Medical Devices and IVD
DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
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.
For questions: office@encotec.at or +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.
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.
NIS2 Requirements and ISO 27001 for AI-based Medical Devices and IVD
Nilaykumar Patel, MSc, MBA
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.
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.
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.
Riskmanagement for AI-based Medical Devices and IVD
DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
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.
For questions: office@encotec.at or +43 1 8863491
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.
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.
Regulations for AI-based Medical Devices and IVD in USA
DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
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.
For questions: office@encotec.at or +43 1 8863491
AI is reshaping the future of medical technology—but how do you stay compliant in a rapidly evolving regulatory landscape? Europe applies one of the world’s most comprehensive frameworks to guarantee the safety, performance, and transparency of medical devices and IVDs, especially those powered by disruptive technologies like AI.
By the end of this seminar, you will have essential insights into MDR, IVDR, and the latest guidance on AI integration. Learn how to align your innovation with EU expectations, avoid regulatory pitfalls, and accelerate your path to market.
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.
Regulations for AI-based Medical Devices and IVD in Europe
DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
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.
For questions: office@encotec.at or +43 1 8863491
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!
Das Online-Forum ist kostenlos.
Gemeinsam mit den Clusterorganisationen LISAvienna, Human.technology Styria, Standortagentur Tirol, ecoplus NÖ, Medizintechnik-Cluster Oberösterreich und Innovation Salzburg erweitern wir wieder die regionalen „MDR Stammtische“ zu einem österreichweiten Online-Forum Roundtable.
In dieser Spezialausgabe geben namhafte Expert:innen der Fachhochschule Technikum Wien einen Einblick in Entwicklungen im Bereich Health Tech und Weiterbildung.
Die enge Kooperation mit der FH Technikum Wien entstand durch die gemeinsame Planung und Organisation des MBA Health Tech Management, der im Herbst 2022 gestartet wurde. Im September 2025 wird bereits der 4. Durchgang starten. Weitere Infos zum MBA
Neben den Expertenvorträgen gibt es daran anschließend wieder die Möglichkeit für individuelle Fragen!
Das Online-Forum ist kostenlos.
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