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!
https://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.png00Hedda Niederlhttps://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.pngHedda Niederl2025-02-04 09:45:032025-02-05 10:37:37SIQ: Online workshop: US Regulation 21 CFR 820 for Medical Devices and Registration Procedures 510(k)
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!
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 new academy cooperation with the Slowenian notified body SIQ!
https://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.png00Hedda Niederlhttps://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.pngHedda Niederl2025-02-04 09:45:032025-02-05 11:42:25SIQ: Online training course: EN ISO 13485:2016 – Quality Management System for the Medical Devices Industry – Basics
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 new academy cooperation with the Slowenian notified body SIQ!
https://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.png00Hedda Niederlhttps://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.pngHedda Niederl2025-02-03 09:45:032025-02-05 11:38:47SIQ: Online workshop: Cybers security of Software in Healthcare and Medical Devices – the Role of the IEC 81001-5-1 Standard
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
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.
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 PhD 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.
This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!
https://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.png00Hedda Niederlhttps://www.encotec.at/wp-content/uploads/2021/04/encotec_logo-space.pngHedda Niederl2024-10-24 09:45:032025-02-05 11:33:22SIQ: Online workshop: Compliance of Medical Device Software (EN 62304)
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.
This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!
About the training
Regulation (EU) 2017/745 on Medical Devices (MDR) also deals with the preparation of a technical documentation to demonstrate conformity of a medical device. A technical documentation has gained in importance in the process of demonstrating compliance, and its preparation is of focal importance. The content and complexity are determined by various factors, especially the classification, intended use, type of a device, specific properties of the product, method of production, etc.
Purpose
Participants get familiar with the requirements relating to medical devices and the current legislation, as well as with the requirements for the conformity of medical devices. Based on practical examples, the participants get to know the tools for identifying the need for compliance of a device with harmonized standards, which directly affects the structure and content of the technical documentation. Based on the acquired knowledge and the consideration of practical examples, the participants prepare a short study – a draft technical documentation for a medical device.
Content
Basic overview of MDR requirements relating to technical documentation
Supporting documents, guidelines (MEDDEV, GHTF and similar)
Structure of a medical device technical documentation
Classification of medical devices
Risk management (EN ISO 14971)
Applicability (EN 62366)
Biological evaluation (ISO 10993)
Sterilization
Clinical evaluation of a medical device
Labelling and instructions for use of a medical device
Construction and implementation documentation
Declaration of conformity
Classification of medical devices
Use of harmonized standards and cases of incorrect application of standards
Preparation of risk assessment documentation
Making a clinical evaluation
Creating a usability record
Making a record of biological evaluation
Preparation of model instructions for use
Preparation of a declaration of conformity
Frequent mistakes and identified good practices of economic operators
After the first two meetings, the participants prepare a short, focused study – a draft technical documentation for a medical device, which they present to the group in the third part of the workshop and exchange good practices.
Dates
13.03.2025: 09:00-15:00
14.03.2025: 09:00-15:00
21.03.2025: 09:00-15:00
Costs
Standard: 1.195,00 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 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.
Ihr Karriere-Sprungbrett zum/r Regulatory Affairs Manager*in!
Am 03. Oktober 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.
Top-Adresse für Beratung zur Medizinproduktezulassung und Ausbildungsakademie für sogenannte "Regulatory Affairs Manager" in der Medizintechnik Branche! Die regelmäßigen Veranstaltungen, wie die LISAvienna oder das "Online-Forum: Regulatory Update", fördern den Know-how-Aufbau und die Vernetzung!
Antwort vom Eigentümer:Lieber Herr Weinfurter, vielen herzlichen Dank für Ihr ausführliches Feedback, das uns sehr freut! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
Wer ein Seminar zum Thema MDR/IVDR und ISO sucht, ist hier gut aufgehoben. DI Martin Schmid spricht aus langjähriger Erfahrung und erklärt Sachinhalte fundiert und verständlich.
Sehr kompetentes und professionelles Team. Vorbehaltlos weiter zu empfehlen
Antwort vom Eigentümer:Lieber Wolfgang Benke, vielen herzlichen Dank für dein tolles Feedback, das uns sehr freut! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
Sehr kompetente Vortragende. Man merkt, dass Sie wissen von was Sie reden. Der Nutzen der Veranstalltung war sogar etwas über meinen Erwartungen. Die Unterlagen wurden vorab per Email zugesandt. Die Möglichkeit nach der Veranstaltung noch Unklarheiten über Telefon oder Email besprechen zu können find ich super und habe ich auch genützt. (Bei der Umsetzung des Gelernten kommen immer Unklarheiten auf) Das einzige was es von mir zu bemängeln gibt ist, dass es sich um eine Online-Veranstaltung handelte und nicht um ein Vorort-Training. Ansonsten, sehr zu empfehlen.
Antwort vom Eigentümer:Lieber Hr. Moritz, vielen herzlichen Dank für Ihr tolles Feedback, das uns sehr freut! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
All the areas of encotec including consulting, academy and auditing provide tailored approach to the customer needs and solutions to your problems due to their vast experience working with the state-of-the-art medical device products and industry best practices! I will highly recommend encotec for your regulatory needs.
Antwort vom Eigentümer:Lieber Nilay Patel, vielen herzlichen Dank für dein positives Feedback! Liebe Grüße, Christa Bachinger
Professioneller Trainingspartner mit hoher Kompetenz und Verlässlichkeit.
Antwort vom Eigentümer:Liebe Frau Sornig, vielen herzlichen Dank für Ihr positives Feedback! Ich hoffe, wir können bald wieder zusammenarbeiten! Herzliche Grüße, Christa Bachinger
Die Beratungsleistungen von encotec sind auf Top- Niveau.
Antwort vom Eigentümer:Lieber Herr Mayer, vielen Dank für Ihr positives Feedback! Das freut uns natürlich sehr! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
Top Partner für QM, Regulatory, Seminare. Seit vielen Jahren ein erfolgreiche Zusammenarbeit!
Antwort vom Eigentümer:Lieber Herr Geyer, wir freuen uns sehr über das tolle Feedback und über unsere langjährige Zusammenarbeit! Alles Gute Ihnen weiterhin, herzliche Grüße, Christa Bachinger
Bei En.co.tec ist man als Hersteller (Start up oder Langzeitplayer) immer super aufgehoben! Relax und fachlich top berät Herr Schmid immer perfekt sowie fachlich perfekt!
Antwort vom Eigentümer:Liebe Frau Zilliner, vielen herzlichen Dank für Ihr sehr erfreuliches Feedback! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
Due to Corona we had an online seminar and were very satisfied with the content and type of presentation - can only recommend it!
Antwort vom Eigentümer:Lieber Herr Weinhäusel, vielen herzlichen Dank für Ihr tolles Feedback, das uns sehr freut! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
Professional experts for Medical Device and in-vitro diagnostics. If you are lost with the regulations and subsequent changes, you are in good hands with en.co.tec
Antwort vom Eigentümer:Liebe Ghazaleh, vielen herzlichen Dank für dein TOP-Feedback, das uns sehr freut! Weiterhin alles Gute! Herzliche Grüße, Christa Bachinger
Kompetente Beratung für Medizintechnik-Unternehmen, man merkt die Erfahrung aus der Praxis. Absolut zu empfehlen
Antwort vom Eigentümer:Lieber Hr. Fröhlich, vielen Dank für das tolle Feedback und die Empfehlung!
Wir freuen uns, wenn wir wieder einmal zusammenarbeiten können! Liebe Grüße, Christa Bachinger
This workshop will be in English and is part of our academy cooperation with the Slowenian notified body SIQ!
