Aktuelle Seminartermine

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

COSTS

• Early bird (until 4 weeks before the seminar): Euro 520,- (excl. VAT)
• Standard (starting 4 weeks before the seminar): Euro 590,- (excl. VAT)
• incl. seminar documentation as PDF and certificate of participation
• Overview of all discounts

YOUR TRAINER

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

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

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

About the training

This seminar takes a system approach to protecting medical devices, systems, networks, and applications from digital attacks.

As technology evolves, the number of active medical devices connected to the outside world through various links is increasing. There are more and more applications and programmes on the market that function as stand-alone medical devices.

New legislation on medical devices has brought additional requirements for managing cybersecurity. Thus, the use of a medical device must take into account its intended purpose and risk class, and potential risks must be managed throughout its life cycle in accordance with the General Safety and Performance Requirements (GSPR) as defined in Annex I to Regulation (EU) 2017/745 (MDR) on Medical Devices.

When demonstrating compliance of a programmable active medical device with medical regulations, it is crucial to ensure that the software is compliant and cybersecure, while also ensuring the device’s effectiveness

Aim

• You will learn about the requirements of medical device legislation in relation to medical software and gain information on how to manage medical device cybersecurity through practical examples.
• You will address the current challenges and guidelines in the field of cybersecurity in medical devices, which are nowadays increasingly exposed to the risk of cyber-attacks.
• You will learn about best practices in establishing a cybersecurity risk management system and focus on potential measures to be taken in the development, installation, and maintenance of medical devices that incorporate software.
• Through practical examples, you will learn how to identify and prevent cyber-attacks on medical devices.
• You will gain knowledge to help you design, develop, and manage safe medical devices that incorporate software.

Content

• Brief description of medical regulatory requirements
• Classification of a product as a medical device
• Determining compliance requirements for a product
• Methods for demonstrating medical software compliance
• Descriptions of software as a medical device
• Integration of medical software management processes into the quality management system
• Demonstrating compliance with the requirements of standards and expected documentation
• Overview of the most important steps in software development from a medical regulatory perspective – practical examples

Target group

• Developers of medical devices that incorporate interoperable software.
• Manufacturers of medical software that is either a stand-alone medical device or a component of a PEMS (Programmable Electrical Medical System).
• Agents or suppliers of medical software.
• Responsible persons for the quality and compliance of medical devices.
• IT staff responsible for maintaining the networks on which the medical devices operate.
• IT network maintenance staff in healthcare institutions.
• Anyone wishing to acquire or upgrade their knowledge of ensuring or demonstrating the compliance of medical software.

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

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.

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

On April 26, 2024, our practice-oriented certificate course will start on all regulatory requirements for medical software and applications in a compact online course. This time the course language is ENGLISH!

5 Days from April 26 until June 7, 2024 | 9am – 4.30pm

Information & Registration for our online certificate course!

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

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 520,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 590,- (exkl. USt.)
• inkl. Seminarunterlagen als PDF und Teilnahmezertifikat
• alle Rabatte im Überblick

Ihr Trainer

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

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

Costs:

• Early bird (until 4 weeks before the seminar): Euro 520,- (excl. VAT)
• Standard (starting 4 weeks before the seminar): Euro 590,- (excl. VAT)
• incl. seminar documents as PDF and a certificate of participation.
• Overview of all discounts

Your Trainer

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

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

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

Kosten

• Frühbucher (bis 4 Wochen vor dem Seminar): Euro 520,- (exkl. USt.)
• Standard (ab 4 Wochen vor dem Seminar): Euro 590,- (exkl. USt.)
• inkl. Seminarunterlagen als PDF und Teilnahmezertifikat
• alle Rabatte im Überblick

Ihre Trainerin

• 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

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