Together with the life science cluster organizations Standortagentur Tirol, LISAvienna, Human.technology Styria, Medizintechnik-Cluster Oberösterreich, ecoplus Niederösterreich and Innovation Salzburg we are once again expanding the regional MDR regulars‘ tables into an online forum roundtable.
This time our roundtable will be in English!
As part of this cross-cluster event, we would like to give you an insight into what to expect in 2026 regarding MDR-IVDR, MDCG and standards. As well as expert presentations and best practice examples, there will again be an opportunity to ask the experts and companies individual questions.
Program
- 16:00 Update: Life Science Cluster Austria
- 16:15 Regulatory Update: MDR, IVDR, MDCG and Standards – Preview 2026
Martin Schmid, en.co.tec - 16:45 EUDAMED To Do’s and UDI-Update
Poppy Abeto Kiesse, GS1 Austria - 17:10 GSPR, Harmonised Standards & Technical Documentation… Without Losing Your Mind. How Startups Can Implement MDR/IVDR in Real Life.
Sabina Nidzworska, Simple Team - 17:40 Q & A
- Each presentation will be followed by an opportunity to ask the experts your specific questions!
The online forum is free of charge.
Click here to register
Do you need support with regulatory requirements or quality management for medical devices or IVDs?
Please take a look at our services for regulatory affairs and quality management.
Contact us for more information! We look forward to supporting you!
Unter Post-Market Surveillance – PMS (Überwachung nach dem Inverkehrbringen) versteht man einen pro-aktiven und systematischen Prozess im Qualitätsmanagementsystem, um aus Informationen über die Qualität, die Leistung und die Sicherheit eines Medizinproduktes, das bereits in Verkehr gebracht wurde, die erforderlichen Schlussfolgerungen zu ziehen und etwaige Präventiv- oder Korrekturmaßnahmen zu implementieren.
Mit der MDR/IVDR erfolgt ein wesentlich stärkerer Fokus auf die Überwachung nach dem Inverkehrbringen. Aber auch alle anderen relevanten Regelwerke wie die ISO 13485:2016 und die ISO 14971:2019 verlangen eine Post-Market Surveillance.
Dieses Seminar gibt einen Überblick über die aktuellen regulatorischen Anforderungen zu diesen wichtigen Themen.
TeilnehmerInnen
Dieses Seminar ist für TeilnehmerInnen ohne Vorkenntnisse zur MDR / IVDR nicht geeignet. Basiskenntnisse zur MDR bzw. IVDR sind empfehlenswert.
Die Seminar-Inhalte
Anforderungen der Überwachung nach dem Inverkehrbringen (Post-Market-Surveillance):
- Anforderungen aus MDR / IVDR (System des Herstellers für die Überwachung nach dem Inverkehrbringen (inkl. PSUR):
- Plan zur Überwachung nach dem Inverkehrbringen
- Technische Dokumentation über die Überwachung nach dem Inverkehrbringen
- Anforderungen aus ISO 13485:2016 Qualitätsmanagement für Medizinprodukte
- Anforderungen aus ISO 14971:2019 Risikomanagement für Medizinprodukte
- Anforderungen aus ISO/TR 20416:2020-07 (neu!)
- Übungsbeispiele
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
The regulatory framework for cybersecurity (IT security) of medical devices is specified in the „General Safety and Performance Requirements“ section of the EU MDR and IVDR regulations. Standards and guidelines specify the requirements for implementation.
In this basic course, you will get an overview of the regulatory relevant standards and documents as well as field-tested tips, methods, tools and useful sources for the implementation of the requirements.
Participants
This basic course is also suitable for participants with little or no previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the topic of cybersecurity for medical device software.
This basic course is part of our online course: Medical Software Specialist!
Seminar contents
- Meaning of key terms from the fields:
- Information Security
- IT Security and
- Operational Security
- Cybersecurity requirements for medical devices from
- applicable standards
- laws and
- guidance documents
- Tips, methods, tools and other useful resources for the implementation of the requirements
Costs
- Early bird (until 4 weeks before seminar): Euro 540,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 610,- (excl. VAT)
- All seminar discounts at a glance
- incl. seminar documents as PDF and a certificate of participation.
Your Trainer
Nilaykumar Patel Msc, Chief Quality Officer (contextflow GmbH) & Co-Auditor at en.co.tec
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.
For questions: 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
Nilaykumar Patel, MSc, MBA
- contextflow GmbH: Head of Quality / PRRC / DPO / CISO
- en.co.tec Schmid KG: Senior Consultant & Lead Auditor
- ISO/IEC/ Technical Committee TC 62: Honorary Technical Expert
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
Unlock the Future of Healthcare!
On February 19th, 2026, the second 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!
With this recognized certificate you can prove your qualifications and competences in the field of AI-based medical devices and IVD!
5 Modules from 19.02.-19.03.2026
Information & Registration for our online certificate course!
Ihr Karriere-Sprungbrett zum/r Regulatory Specialist!
Am 27. Februar 2026 startet der nächste Durchgang unseres Online-Lehrgangs: REGULATORY SPECIALIST EU für Medizinprodukte und In-vitro Diagnostika nach MDR / IVDR!
Mit dieser praxis- und umsetzungsorientierten Weiterbildung bieten wir eine Gesamtsicht auf alle relevanten Themen der EU-Verordnungen für Medizinprodukte MDR und In-vitro Diagnostika IVDR in einem kompakten Online-Lehrgang!
- 7 Module = 7 Tage
- 27.02. – 22.05.2026
- Abschluss mit Zertifikat!
Your career stepping stone into the world of medical software & apps!
The next round of our practice-oriented course on all regulatory requirements for medical software and apps will start on April 10, 2026. The course will be taught in English!
With this recognized certificate, you can demonstrate your qualifications and expertise in the field of medical software.
- 5 modules = 5 days (9am-4.30pm – ONLINE)
- Next Start: 10.04. – 07.05.2026
- Conclusion with online-exam and certificate!
Information & Registration for our online certificate course!
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[…] Wir empfehlen Ihnen, die verbleibende Zeit zu nützen und die Anforderungen an die UDI-Kennzeichnung Ihres Medizinprodukts bzw. In-vitro Diagnostikums umzusetzen. Dann sind Sie rechtzeitig fit für die Registrierung in EUDAMED! Hier geht’s zu unseren aktuellen UDI-Seminarterminen. […]
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