Aktuelle Seminartermine

AI for medical devices: Safety, Reliability and Compliance: this workshop will provide you with a comprehensive understanding of the legal and technical requirements for the use of Artificial Intelligence in medical devices.

We highlight the key provisions of the EU-AI Act, the EU-Medical Device Regulation (MDR) and relevant standards. In addition, we will address aspects of the technical reliability of AI systems and provide sufficient space for your questions.

SEMINAR CONTENT

• AI, trustworthiness and MedTech
• AI governance – requirements for the use of AI from the AI Act, MDR-IVDR and standardisation
• Technical reliability
• Q&A

PARTICIPANTS

This basic course is also suitable for participants with little or no previous knowledge.

COSTS

• Early bird (until 4 weeks before the seminar): Euro 250,- (excl. VAT)
• Standard (starting 4 before the seminar): Euro 295,- (excl. VAT)
• All seminar discounts at a glance
• incl. seminar documents as PDF and a certificate of participation

YOUR TRAINER

Andreas Gruber, Managing Director of TRUSTIFAI GmbH with over 10 years of experience in the design, testing and acceptance of safety-critical software systems in the deep tech sector.

TRUSTIFAI GmbH, based in Hagenberg / Austria, is a joint venture of TÜV Austria and SCCH, in cooperation with the Machine Learning Institute at the JKU of Prof. Sepp Hochreiter. It is the Austrian testing and certification hub for AI and machine learning applications.

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.

Book now!

Click here for online registration.

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

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.

Teilnehmer*innen

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 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

Ihr Karriere-Sprungbrett zum/r Regulatory Affairs Manager*in!

Am 23. Jänner 2025 startet der nächste Durchgang unseres Online-Lehrgangs: REGULATORY SPECIALIST für Medizinprodukte und In-vitro Diagnostika nach MDR / IVDR!

Wir bieten mit dieser praxis- und umsetzungsorientierten Weiterbildung eine Gesamtsicht auf alle relevanten Themen der MDR / IVDR in einem kompakten Online-Lehrgang.

• 7 Module = 7 Tage
• 23.01. – 09.05.2025
• Abschluss mit Zertifikat!

Alle Infos zu unserem Online-Regulatory-Specialist-Lehrgang

This seminar will be held in English.

The development of standalone software such as mobile medical applications but also the integration of software as a component in medical devices means a complex challenge for many medical device manufacturers in the intersection of technology, regulations and clinical evidence.

In this seminar, you will gain an overview of the regulatory framework and familiarize yourself with the specifics of placing medical software on the market. The requirements for classification and conformity assessment procedures of medical software in the most important markets will be shown to you in a practical manner and using current examples.

You will learn about all phases of the product lifecycle of medical software, starting with development, through initial marketing, to software maintenance (i.e. updates and bug fixes). We will show you what is important when placing products on the market in the most important markets and how you can integrate the required processes into your quality management system in a meaningful way.

PARTICIPANTS

This basic course is suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the legal framework for medical software development.

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

SEMINAR CONTENT

Basic regulatory requirements in Europe and the USA

• Overview of regulatory frameworks for medical software
• Decision support for the classification of software as a medical device
• Special features of standalone incl. mobile medical applications („APP“) and embedded software
• Classification principles for medical software
•  Exercises:
  • How to use the digital health policy navigator (USA-FDA)
  • How to classify your medical software / app
  • General Safety and Performance Requirements (Template-Matrix)

Selected requirements

• Product development processes
• Digressions
  • Agile development process
  • EU Regulations MDR / IVDR – General Safety and Performance Requirements

YOUR TRAINER

• Martin Schmid, Managing Director & Senior Consultant at 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. VAT)
• incl. seminar documentation as PDF and 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 (eg Firefox, Safari or Chrome). 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

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

On January 30, 2025, our practice-oriented course will start on all regulatory requirements for medical software and applications in a compact online course. The course language is ENGLISH!

5 Days from January 30 until April 23, 2025 | 9am – 4.30pm

Information & Registration for our online certificate course!

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

About the training

The course will present the requirements of the EN ISO 13485:2016 standard for the quality management system in the production of medical devices (and related services) and related legislation applicable to the field of medical devices.

Medical devices placed on the market must comply with the Regulation (EU) 2017/745, which applies to each individual product of a particular type or model and it has in certain areas has a significant impact on both the QMS and the devices themselves.

Intention

The basic purpose of the standards is to facilitate the harmonization of legal requirements applicable to this area. In the course you will gain knowledge that will help you in:

• establishing and / or maintaining a quality management system,
• preparation of documentation or technical files for medical devices,
• obtaining the CE certificate for medical devices,
• effective implementation of internal audits.

Content

• Review of the requirements of EN ISO 13485: 2016; Medical devices – Quality management system – Requirements for legislative purposes
• Comparison with ISO 9001 requirements, with emphasis on specific requirements for development, infrastructure and working environment, traceability, and reporting
• Risk management
• Familiarization with the requirements of the medical directive and the activities necessary to meet the requirements
• Regulation (EU) 2017/745
• Internal auditing – purpose, planning, preparation, implementation, reporting
• Case study: recording of nonconformities and simulation of assessment
• Written knowledge test

At the end of this course, participants will be able to:

• Understand the requirements of ISO 13485:2016 for medical products and related services
• Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
• Acquire the skills to take on the position of Internal Medical Services Auditor in their company

Dates

• 17.02.2025: 09:00-15:00
• 18.02.2025: 09:00-15:00
• 19.02.2025: 09:00-15:00

Costs

• Standard: 1.235,00 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 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.

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.

Die allgemeinen Sicherheits- und Leistungsanforderungen der neuen EU-Verordnungen für Medizinprodukte (MDR) und für In-vitro Diagnostika (IVDR) sind die Basis für ein Konformitätsbewertungsverfahren. Hersteller wenden dafür vorrangig harmonisierte Normen an, um die Konformität mit diesen Anforderungen nachzuweisen. Anhand von Checklisten mit den entsprechenden Normen kann dies effizient erarbeitet werden.

Dieses Seminar gibt einen Überblick über die allgemeinen Sicherheits- und Leistungsanforderungen lt. MDR und IVDR. Anhand einer ausführlichen Checkliste zeigen Ihnen die beiden Trainer, welche harmonisierten Normen für Ihr Produkt einzuhalten und wie sie anzuwenden sind.

Teilnehmer:innen

Dieses Seminar ist für Teilnehmer:innen ohne Vorkenntnisse NICHT geeignet. Sie benötigen Grundkenntnisse zu den Konformitätsbewertungsverfahren und zur Erstellung der technischen Dokumentation für Medizinprodukte und / oder IVD.

Die Seminar-Inhalte

• Überblick General Safety and Performance Requirements
• GSPR für Medizinprodukte
• GSPR für In-vitro Diagnostika
• Anforderungen der relevanten Normen im Überblick
• Methodik & Checklisten
• Übungsbeispiele

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

Ihre Trainer:innen

• Mag. Marie Salin, Managing Director, West Medica Produktions- und Handels-GmbH – erfahrene Regulatory Expertin für IVD, Beraterin, Trainerin und zertifizierte interne Auditorin
• 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 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

This seminar will be held in English.

During the seminar, the standards IEC 62304:2006, standards IEC 62304-1:2015 Amendment 1 and IEC 82304-1:2016 and other international regulations will be presented in a practical manner. The implementation of these software standards is a challenge for many manufacturers of medical devices – especially for newcomers and start-ups – as a whole range of partly new processes is required. You will get a basic overview of the essential contents of the standards with the required processes that describe the software lifecycle.

In this seminar you will learn the relevant standards, laws, regulations, guidelines and methods, for example how to implement your agile software development compliant with regulatory requirements, you will learn how to integrate third party software („SOUP`s“) into your medical device compliant with standards and how to document it.

By means of practice-relevant exercises, the handling of the standard will be deepened and the implementation with regard to process design and documentation will be practiced. The aim of the seminar is to learn the requirements for the development and approval of medical software and to be able to implement them for your own application.

Participants

This basic course is also suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the implementation of IEC 62304 and IEC 82304-1.

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

Seminar contents

• Definitions of terms
• Overview of relevant regulations and standards and connection with other essential standards for medical devices
• Requirements of the software standard IEC 62304 (Software for medical devices – Software life cycle processes)
  • Software Safety Classification
  • Software-Development Process
  • Software Maintenance Process
  • Software Risk Management Process
  • Software Configuration Process
  • Software Problem Solving Process
• Overview IEC 82304-1 (Health software — Part 1: General requirements for product safety)
• Validation of medical device software
• Implementation of the standard in existing medical software (Legacy Software)
• Group work & exercises

Your Trainer

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. VAT)
• 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 any questions: office@encotec.at oder +43 1 8863491