Events & Seminare

Der Einsatz von Digital Health und KI birgt enormes Potenzial. Aber auch Risiken, die durch fehlende Compliance entstehen können!

Bei der en.co.tec Frühlingsakademie zeigen Ihnen unsere Experten:

• wie Sie die komplexen regulatorischen Anforderungen der EU im Bereich Digital Health, Artificial Intelligence und Cybersecurity meistern,
• in Ihre Compliance-Strategie integrieren und
• dadurch Ihre Medizinprodukte und In-vitro Diagnostika zukunftssicher machen!

Alle Infos zur Frühlingsakademie 2025 als PDF zum Download – hier klicken!

Was erwartet Sie?

• 1. Tag: Experteninfos zu den regulatorischen Anforderungen an Digital Health, Cybersecurity auf Unternehmens- und Produktebene und dem EU-AI-Act! Plus pragmatische Ansätze und Best-Practice-Einblicke als Vorlage für Ihre Umsetzung!
• 2. Tag: Hands-on Workshop: Erarbeitung einer Compliance-Strategie in Kleingruppen unter Anleitung unseres Experten-Teams! Wie lassen sich die Themen vom 1. Tag in eine individuelle Compliance-Strategie integrieren?

Warum Sie dabei sein sollten:

• Praxisnahe Inhalte: Erfahren Sie, wie Sie die neuen EU-Regularien in Ihren Alltag integrieren. Lernen Sie von Top-Experten mit langjähriger Erfahrung! Zahlreiche Best Practice Tipps!
• Schützen Sie Ihr Unternehmen: Vermeiden Sie hohe Strafen und Image-Schäden.
• Bleiben Sie wettbewerbsfähig: Setzen Sie auf zukunftsorientierte Lösungen.
• Networking: Tauschen Sie sich mit unseren Experten und den anderen TeilnehmerInnen aus und knüpfen Sie wertvolle Kontakte.
• Perfekte Lernumgebung: Unser Seminarhotel liegt umgeben von Weingärten südlich von Wien!

TeilnehmerInnen

Sie arbeiten im Bereich Regulatory Affairs, Qualitätsmanagement, Risikomanagement oder Geschäftsführung in einem Medizinprodukte- oder IVD-Unternehmen? Dann sollten Sie unser 2-tägiges Seminar nicht verpassen!

Ehemalige TeilnehmerInnen unserer Online-Lehrgänge erhalten einen Spezial-Rabatt – gleich hier anfragen: seminare@encotec.at!

Programm am 15. Mai 2025:
Regulatorische Anforderungen für Digital Health, AI und Cybersecurity

Ziel: Verstehen der Anforderungen und Veranschaulichung der Umsetzung durch Best Practice – Beispiele

• Regulatorische Anforderungen für Digital Health, Artificial Intelligence und Cybersecurity in der EU berücksichtigen & umsetzen!
  Martin Schmid, Senior-Consultant & Geschäftsführer, en.co.tec
  
• Pragmatische Managementansätze für Informationssicherheit und Künstliche Intelligenz
  Harald Erkinger, Geschäftsführer, CIS – Certification & Information Security Services GmbH: CIS ist österreichischer Marktführer für die Zertifizierung von Informationssicherheit gemäß ISO 27001, führender Prüfer von NIS und NIS-2 und weltweit einer der ersten Zertifizierer von ISO 42001 KI Management.
• KI in Medizinprodukten – Was bedeutet dies für die Konformitätsbewertung?
  Florian Heffeter, CEO, QMD Services GmbH: QMD Services ist die einzige benannte Stelle für MDR und IVDR mit Sitz in Österreich.
• Best Practice: NIS2 Anforderungen und ISO 27001
  Markus Speiser, Prokurist, Legal Counsel, PRRC, Data Privacy Officer bei synedra information technologies GmbH: synedra bietet Lösungen für das Management von Daten im Gesundheitswesen. Mit der Health Content Management Plattform synedra AIM hilft synedra seinen Kunden dabei, ihre Workflows für die Behandlung von Patient*innen effizient und qualitätsvoll zu organisieren.
• Best Practice: Implementierung EU-AI-ACT und MDR-Cybersecurity
  Nilaykumar Patel, Head of Quality, PRRC, DPO, CISO bei contextflow GmbH – Auditor & Senior Consultant bei en.co.tec

Programm am 16. Mai 2025:
Hands-On Workshop zur Strategieentwicklung

Ziel: Entwicklung einer individuellen regulatorischen Compliance-Strategie für die Themen des 1. Tages.

• Einführung in die Entwicklung einer regulatorischen Compliance-Strategie für Cybersecurity, NIS2, EU-AI-Act und Überschneidungen mit MDR, IVD
  Martin Schmid, Nilaykumar Patel und Markus Speiser (siehe 1. Tag)
  
• Arbeit in Kleingruppen: Entwurf einer individuellen Compliance-Strategie
  mit Unterstützung durch unsere Experten
• Präsentation der Strategie-Entwürfe durch die Kleingruppen & individuelles Feedback von unseren Experten
  
• Arbeit in Kleingruppen: Finalisierung der Compliance-Strategie: Integration des Feedbacks und Erstellung eines Abschlussdokuments
• Abschlussdiskussion und Tipps für die Implementierung

Teilnahmebeitrag – Frühbucher-Rabatt

Der 1. Tag ist einzeln buchbar, der 2. Tag nur in Kombination mit dem 1. Tag.

• Frühbucher-Preis bis 10.03.2025:
  • 1. Tag: Euro 570,-
  • beide Tage: Euro 1.110,- (exkl. USt.)
• Standard-Preis ab 11.03.2025:
  • 1. Tag: Euro 640,- (exkl. USt.)
  • beide Tage: Euro 1250,- (exkl. USt.)

Stipendium & Rabatte:

• Wir vergeben zwei Stipendien à € 290,-! Hier für ein Stipendium bewerben!
  
• Ehemalige TeilnehmerInnen unserer Online-Lehrgänge erhalten einen Spezial-Rabatt – gleich hier anfragen: seminare@encotec.at!
• Alle weiteren Rabatte

Infos & Anmeldung:

• Für Ihre Online-Anmeldung hier klicken!
• PDF-Download: Frühlingsakademie 2025 – alle Infos
• PDF-Download: Programm im Detail
• Die Anmeldung ist bis 10. April 2024 möglich. First-come, first-served! Begrenzte Teilnehmerzahl, damit ausreichend Gelegenheit für Fragen und persönliche Gespräche bleibt.

Veranstaltungsort:

Freigut Thallern
2352 Gumpoldskirchen

https://www.freigut-thallern.at/

Für Online-Anmeldung hier klicken!

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

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

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.

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.

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

Sterilization is one of the key processes in the production of sterile medical devices. Among the different sterilization types, each has its advantages and disadvantages. Evidence of successful sterilization is important and expected when demonstrating conformity with regulatory requirements.

Intention

The workshop will address the following topics related to medical device sterilization: microorganisms and their characteristics, bioburden determination for medical devices, controlled environments, clean rooms in the production of medical devices, cleaning and sterility assurance for reprocessed medical devices, and sterile barrier systems. Through the presentation of practical examples, the attendees will learn the details of compliance assurance and get the knowledge for competent performance of medical device sterilization.

Content

• Basic sterility – microorganisms and their characteristics, medical devices’ bioburden, controlled environments and cleanrooms, cleaning and sterility assurance processes with a sterile barrier system.
• Requirements for the sterility of medical devices according to medical device directives and regulations, ISO 17665-1, and other harmonized standards regarding the sterilization of medical devices.
• Presentation of the different sterilization types (steam, dry, gas, radiation)
• The importance of contamination control of work environments and sterilization processes in relation to ISO 13485
• Procedures for the confirmation of successful sterilization of medical devices (control, validation, sterility)
• Packaging and release of sterile medical devices
• Review of the most important sterilization methods used in the medical device industry – practical cases

Methodology

The workshop will cover the theoretical basics and requirements through practical examples and exchange of experience.

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 wor 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 academy cooperation with the Slowenian notified body SIQ!

What are products without an intended medical purpose?

• Contact lenses or other items intended to be introduced into or onto the eye.
• Products intended to be totally or partially introduced into the human body for the purpose of modifying the anatomy or fixation of body parts.
• Substances intended to be used for facial or other dermal or mucous membrane filling and equipment intended to be used to reduce or remove adipose tissue.
• High intensity electromagnetic radiation emitting equipment for use on the human body and transcranial brain simulation equipment.

Annex XVI to Regulation (EU) 2017/745 includes a list of categories of devices without an intended medical purpose. These are devices based on similar technology as medical devices and used in a similar way but with a non-medical purpose. As the named product groups present certain risks when in use, they are expected to be controlled in accordance with the Regulation and, where necessary, to be subject to a clinical safety assessment.

Aim

The e-training will introduce the participants to the procedure and provide information on how to prepare the necessary documentation to properly document a device without an intended medical purpose.

Content

• Brief description of medical regulatory requirements
• Products without an intended medical purpose to which Regulation (EU) 2017/745 applies
• Determination of conformity requirements for a product – presentation with practical examples:
  •   The manufacturer’s or authorised representative’s declaration
  •   Measures to ensure manufacture in accordance with the documentation
  •   Preparation of the documentation – risk management and clinical evaluation/prescription and post-market monitoring of the product

Target group

• Process operators and the representatives of manufacturers of devices without an intended medical purpose.
• Anyone wishing to acquire or upgrade their knowledge of ensuring or demonstrating the conformity of devices listed in the group of products without an intended medical purpose.

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

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.

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

About the training

Regulatory requirements for medical devices on US, European, or other global markets differ. Prior to a successful sale on the US market the medical device shall be registered (e.g. procedure acc. 510(k)), and should adhere to the quality system regulation principles outlined in acc. 21 CFR 820.

Intention

Attendees will be informed of the main regulation for medical devices on the US market, 21 CFR 820, and other related regulations for medical devices (e.g. 21 CFR 803, 806, 11). The basic principles of registration processes such as 510(k) will also be discussed using practical cases.

Content

• Presentation of the regulations and requirements for medical devices on the US market with practical cases and discussions
• Methodology and registration documentation preparation
• Presentation of the registration process, assurance of compliance for FDA inspections

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

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. 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

Biocompatibility of medical devices is an important characteristic of safe and compliant medical devices. The main steps for ensuring biocompatibility are specified in ISO 10993-1 standard.

Intention

Attendees will participate in a workshop on the preparation of medical device biological evaluation reports covering chemical characterization of materials, documentation preparation, and justification of testing performance or its omission (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, carcinogenicity). All these issues will be discussed through practical examples.

Content

Presentation of requirements for biological safety evaluations of medical devices in medical device directives and regulations, as well as ISO 10993-1 and other relevant standards• Review of the ISO 14971 standard in relation to biological safety – preparation of a biological evaluation report concerning biological risks Methodology and biological evaluation report preparation• Summary of ISO 10993-1 with practical discussions.

Methodology

The workshop is will cover the theoretical basics and requirements through practical examples and an exchange of experiences.Attendees may send their questions at registration prior to the workshop.

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 wor 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!

Unlock the potential of your medical product development with our comprehensive lecture series on Medical Requirements Gathering. Designed for healthcare professionals, IT specialists, and product managers, our course provides the essential knowledge and practical skills needed to gather, document, and manage requirements effectively, ensuring your medical products meet user needs, regulatory standards, and market demands.

Why Attend Our Lecture Series?

1. Industry-Specific Insights:

Gain a deep understanding of the unique challenges and considerations in the healthcare domain, including patient safety, regulatory compliance, and data privacy.

2. Comprehensive Stakeholder Engagement:

Learn techniques for identifying and prioritizing key stakeholders such as patients, healthcare providers, and regulatory bodies to ensure all critical perspectives are captured.

3. Regulatory and Compliance Mastery:

Navigate complex healthcare regulations like HIPAA, GDPR, and FDA standards with confidence, ensuring your products comply with all necessary legal requirements.

4. Practical Requirements Gathering Techniques:

Master various techniques including interviews, surveys, observations, and workshops to gather precise and actionable requirements directly from your users.

5. Effective Documentation and Management:

Utilize best practices and tools for documenting, managing, and maintaining requirements, ensuring traceability and alignment with project goals.

6. User-Centered Design Principles:

Implement user-centered design methodologies to create intuitive and effective medical products that meet the real needs of end-users.

7. Addressing Challenges and Ensuring Success:

Overcome common challenges such as miscommunication, scope creep, and stakeholder conflicts with proven strategies and best practices.

8. Ethical and Privacy Considerations:

Ensure your products adhere to the highest ethical standards and protect patient privacy throughout the development process.

9. Keeping Up with Emerging Trends:

Stay ahead of the curve with insights into the latest trends and technologies in healthcare, such as AI, IoT, and telemedicine, and their impact on requirements gathering.

10. Hands-On Case Studies and Practical Examples:

Learn from real-world case studies and practical examples that illustrate successful requirements gathering and product development in the medical field.

Why Choose Us?

Our lecture series is tailored to equip your team with the essential skills and knowledge required for successful medical product development. By attending, you’ll ensure your products are user-friendly, compliant, and positioned for success in the competitive healthcare market.
Invest in your team’s expertise and the future success of your medical products. Join us for this invaluable lecture series and transform your approach to medical requirements gathering.

Costs

• Standard: 395,00 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.

Die Technische Dokumentation ist die Grundvoraussetzung für eine Produktzulassung als Medizinprodukt oder In-vitro Diagnostika. Dieses Seminar erklärt Schritt-für-Schritt, wie die technische Dokumentation aufgebaut sein soll, damit alle Anforderungen der neuen EU-Verordnungen (MDR / IVDR) erfüllt werden.

TeilnehmerInnen

Dieser Basiskurs ist auch für TeilnehmerInnen ohne Vorkenntnisse geeignet. Für Branchen-Quereinsteiger und Start-Ups bietet dieser Kurs einen optimalen Einstieg in die gesetzlichen Rahmenbedingungen für die Zulassung von Medizinprodukten und In-vitro Diagnostika.

Die Seminar-Inhalte

• Überblick zu den Anforderungen durch die EU-Verordnungen (IVDR / MDR)
• Aufbau und Inhalt der Technischen Dokumentation
• Definitionen und Grundanforderungen
• Allg. Anforderungen nach MDR/IVDR Anhang II
• Spezielle Anforderungen MDR Anhang II
• Spezielle Anforderungen IVDR Anhang II
• Anhang VIII: Klassifizierungsregeln für Medizinprodukte und IVD
• Übungsbeispiele zu Zweckbestimmung, Klassifizierung und viele Praxis-Tipps

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

Ihr Trainer

DI Martin Schmid, Geschäftsführer & Senior Consultant bei 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 Teilnahmebestätigung
• 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