Online-Roundtable: Regulatory Update for Medical Software, Apps, Digital Health and AI (English)

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Together with the cluster organizations Standortagentur Tirol, LISAvienna, Human.technology Styria, Medizintechnik-Cluster Oberösterreich and ecoplus Niederösterreich, we are once again expanding the regional MDR regulars‘ tables into an Austria-wide online forum roundtable.

Our roundtable on May 13 will be our first one in English!

As part of this cross-cluster event, we would like to give you a regulatory update on MDR-IVDR.

This session will focus on what manufacturers need to know about Medical Device as Software under MDR with reflections on the impact of AI.

Program

  • 16:00 Update: Life Science Cluster Austria
  • 16:15 Regulatory Update: Medical Device Software & Apps, Digital Health and Art. Intelligence
    Martin Schmid, en.co.tec
  • 16:40 Challenges for Medical Device Software under MDR
    Sreenath Sukumaran – Senior Technical Specialist & Scheme Manager, Active Medical Devices – BSI Regulatory Services
  • 17:20 Best Practice: Medical Software, Apps, KI under MDR
    N.N., Health Pioneers, Verband Digitale Gesundheitsversorgung Österreich
  • 17:40 Standards for artificial intelligence in medical devices: what we have – what we need – what we can expect!
    Volker Sudmann, mdc medical device certification
  • 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

SIQ: Online-Workshop: Biocompatibility of Medical Device

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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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

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

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

 

SIQ: Online workshop: Compliance of Medical Device Software

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

About the training

To prove the conformity of a programmable active medical device or stand-alone software with medical directives, it is necessary to provide safe, effective, and compliant software.In the case of software as a stand-alone medical device or as part of an active medical device, the requirements of EN 62304 standard are used to demonstrate compliance, and the organization must have ISO 13485 quality management system in place.Join our workshop about the requirements of medical directives applicable to medical software and learn how to establish compliance through practical examples.

Content

  • Brief description of the requirements of medical directives
  • Classification of the product as a medical device
  • Defining conformity requirements for the product
  • Ways to demonstrate the compliance of medical software
  • Descriptions of software as a medical device
  • Integration of medical software management processes into the quality management system
  • Demonstration of compliance with the requirements of the standards and expected documentation
  • An overview of the most important points in software development from the point of view of medical directives – practical examples

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

Rok Hrovatin started assessing the risk of medical devices only a few years before Slovenia’s accession to the EU. The transposition of European directives has established requirements in this area with the Medical Devices Directive (MDD 93/42 / EEC). He gained experience and knowledge as the head of the testing laboratory for medical devices at SIQ, and soon after that also as a leading auditor in the field of medical devices and as a lecturer in this field.

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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

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

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

 

SIQ: Online course: Guidelines for Managing Medical Device Cybersecurity in Design, Installation, and Maintenance

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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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

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

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

 

SIQ: Online course: Products Without an Intended Medical Purpose – Regulation (EU) 2017/745, ANNEX XVI

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This workshop will be in English and is part of our new 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

Work method

  • The e-training will take place in a live virtual classroom.
  • You will receive a link to the online training two days before the event.
  • To participate in the online training, you will need a computer with a microphone and a camera and a reliable internet connection.

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

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 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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

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

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

 

SIQ: Online-Workshop: Clinical evaluation of medical devices by literature

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

About the training

Clinical evaluation is mandatory for all medical devices under the MDR. An important part of the clinical evaluation is the thorough review and evaluation of published clinical data on your medical device and analogous devices. Conducting a systematic literature review helps support the intended use of your device and confirm its safety profile by demonstrating that it poses minimal risks or that its benefits outweigh the potential risks. A comprehensive analysis of published clinical data in peer-reviewed publications, medical guidelines and published reports can also show that your product is superior to existing alternatives. Therefore, a high-quality leterature review with pragmatic approach is needed to produce quality data output for your clinical evaluation report.

Intention

In this workshop you will learn the most important steps for preparing a clinical evaluation of a medical device based on a literature search.

Content

  • Optimization of your search term strategy
  • Identification of relevant publications
  • Reasons for inclusion and exclusion of published data/notes/articles/reports
  • Evaluation and weighting of clinical data
  • Effective summarization of data
  • Use of multiple data sources
  • Documentation of references

Methodology

Examples of best practice, exchange of experiences, work on concrete practical examples.

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

Dr. Mojca Fir holds a PhD in chemistry and has more than 8 years of experience in human clinical research, mainly for medical devices and food supplements. As a clinical trial project manager, she is familiar with and involved in all phases of clinical trial development, from designing the clinical trial protocol and supporting documentation, obtaining a favourable ethics committee opinion and approval from the competent authority, conducting and monitoring clinical trials in healthcare facilities, data collection and analysis, and preparing the final clinical trial report. She works as director and clinical trial project manager in a CRO (Clinical Research Organisation).

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.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

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

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

 

START: Online-Lehrgang: REGULATORY SPECIALIST MDR-IVDR

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

Am 03.05.2024 startet der 3. Durchgang unseres neuen 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
  • 03. Mai – 26. Juni 2024
  • Abschluss mit Zertifikat!

Alle Infos zu unserem Online-Regulatory-Specialist-Lehrgang

Hier gehts direkt zur Anmeldung

ExpertInnen Talk „Digitalisierung im Gesundheitswesen – Herausforderungen für Digitale Medizinprodukte und In-vitro-Diagnostika“

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Digitalisierung entwickelt sich auch im Gesundheitswesen rasant; laufend werden neue Anwendungs- und Unterstützungsmöglichkeiten geschaffen.

Die Fachveranstaltung „Digitalisierung im Gesundheitswesen“ legt den Fokus auf die Entwicklung von Software als Medizinprodukt oder zur Steuerung von In-vitro-Diagnostika. Weiters beschäftigen sich die Referentinnen und Referenten mit dem Umgang mit der Zulassung und Registrierung von Medizinproduktesoftware sowie dem Status der EU-Medizinprodukteverordnung. Auch das Thema Cyber-Sicherheit kommt nicht zu kurz.

Die Veranstaltung richtet sich an Medizintechnikhersteller – vom Rollator bis MR – sowie Hersteller von IVD, Mitarbeiter und Mitarbeiterinnen aus Landesgesundheitsagentur (Shared Services IT) und an Forscher und Forscherinnen aus dem Bereich Medizinprodukte und IVDs.

Programmvorschau

  • Begrüßung: ecoplus Plattform für Gesundheitstechnologie
  • Austromed, Philipp Lindinger: „Status eHealth-Strategie und DiGA-Erstattung in Österreich“
  • Hofstätter IT, Alexander Hofstätter und Dr. Peter Klar: „Erfahrungen als Anbieter und Serviceleister im Bereich Digitalisierung im Medizinprodukte Bereich“
  • en.co.tec, Martin Schmid: „Regulatorische Anforderungen an künstliche Intelligenz, Digital Health und Cybersecurity“
  • ACMIT, Bernhard Nußbaumer: „Wie bringt man innovative Ideen erfolgreich zur klinischen Anwendung?“
  • Competence Center Medizintechnik, Marco Pontasch: „Erfahrungen als Lead Buyer, Regionalkoordination NÖ Mitte“
  • MDC, Volker Sudmann: „Validierung von Software-Anwendungen im Qualitätsmanagement“

Veranstaltungsort:

Haus der Digitalisierung, Konrad-Lorenz-Straße 10, 3430 Tulln an der Donau

Veranstalter:

ecoplus / Plattform Gesundheitstechnologie NÖ

JETZT ANMELDEN!

 

 

Basic course: Cybersecurity – IT security for medical devices

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This seminar will be held in English.

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 no or little 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 520,- (excl. VAT)
  • Standard (starting 4 weeks before the seminar): Euro 590,- (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.

 

START: Online-Course: MEDICAL SOFTWARE SPECIALIST

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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!