Events & Seminare

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!

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

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

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 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!

An important part of the technical documentation of a medical device is its clinical evaluation, which, according to the MDR, should be based on a review of the relevant literature of identical or similar medical devices or the results of the medical device’s clinical investigation and the results of post-market clinical follow-up of the medical device.

For the auditor of a clinical evaluation, the results of the clinical investigation of a given medical device are essential for a positive assessment of its safety and efficacy. It is therefore very important that the clinical investigation of a medical device is planned and conducted in accordance with good clinical practice and ISO 14155 standard.

Aim

This workshop will provide you with an overview of the key elements of the clinical investigation of a medical device that influence the credibility of the results and, consequently, the clinical evaluation of the medical device. Therefore, the workshop presents in more detail:

• the phases of a clinical investigation,
• the key documents of the investigation, which include:
  • the approved investigation plan,
  • traceability of the conduct of the investigation,
  • data processing and analysis, and
  • presentation of the results of the investigation.

The knowledge you gain will enable you to:

• monitor the planning and conduct of a clinical investigation of your medical device,
• determine the indication(s) or intended clinical use of your medical device; and
• identify potential weaknesses in the emerging clinical evaluation, especially for those medical devices that may have multiple intended use, whereas the clinical investigation can often evaluate only one intended use.

Content

• Types of clinical investigations with medical devices
• Key phases of a clinical investigation
• Clinical documentation – clinical investigation plan (protocol), patient information and informed consent (ICF), clinical data collection form (CRF), patient diary, investigator brochure, investigation marketing materials
• Clinical investigators
• Patient recruitment strategy
• Procedure for obtaining the opinion of the Ethics Committee and the approval of the competent authority for medical devices
• Initiation of the investigation
• Supervision of the conduct of the investigation
• Challenges and obstacles in the conduct of the investigation
• Data collection, processing, and analysis
• Preparation of the investigation report
• Conclusion of the investigation

After the first meeting, participants prepare a short, focused paper – a draft clinical investigation plan for a medical device and present it to the group during the second part of the training.

Target Group

• Medical device manufacturers.
• Medical device developers.
• Responsible persons for the preparation of a clinical evaluation.
• Anyone wishing to acquire or upgrade their knowledge of the clinical investigation of a medical device.

Dates

• 19.08.2025: 09:00-15:00
• 20.08.2025: 09:00-15:00

Costs

• Standard: 715,00 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 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 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.

TeilnehmerInnen

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 Teilnahmebestätigung
• 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.

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 confirmation 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!

Our practice-oriented course on all regulatory requirements for medical software and applications in a compact online course. The course language is ENGLISH!

5 Days from October 10 until December 17, 2025 | 9am – 4.30pm

Information & Registration for our online certificate course!