Aktuelle Seminartermine

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.

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

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

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

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.