Basic course: Development of software for medical devices

in , , , , ,

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

 

Basiskurs: Klinische Prüfung & Bewertung von Medizinprodukten und IVD

in , , , , , ,

Dieser Basiskurs deckt die wichtigsten Aspekte der klinischen Prüfung und klinischen Bewertung in Übereinstimmung mit den europäischen Medizinprodukte-Vorschriften und den geltenden Leitfäden ab.

Sie lernen, wie man klinische Daten plant, generiert, dokumentiert, analysiert und einen qualitativ hochwertigen klinischen Bewertungsbericht erstellt, der für die Regulierungsbehörden und benannten Stellen akzeptabel ist. Wir zeigen Ihnen, wie sich der Prozess in die Entwicklung eines Medizinproduktes und auch in die Post-Market-Aspekte der klinischen Evidenz einfügt.

TeilnehmerInnen

Dieser Basiskurs ist auch für TeilnehmerInnen ohne Vorkenntnisse oder mit geringen Vorkenntnissen geeignet, für Branchen-Quereinsteiger und Start-Ups bietet dieser Kurs einen optimalen Einstieg in die gesetzlichen Rahmenbedingungen für die klinische Bewertung und Prüfung von Medizinprodukten und In-vitro Diagnostika.

Die Seminar-Inhalte

  • Regulatorische Rahmenbedingungen
    • Klinische Evidenz
    • Klinischer Benefit
    • Klinische Leistungsbewertung
  • Klinische Evaluation
    • Nachweise für die Einhaltung der grundlegenden Anforderungen an Sicherheit und Leistung
    • Welche Daten benötige ich für die klinische Evaluation
    • Zusammensetzung des Klinischen Evaluationsberichts
  • Was ist eine klinische Prüfung?
    • Regulatorische Rahmenbedingungen für klinische Prüfungen
    • Ethikkommission
    • BASG
    • Dokumente bei Einreichung von klin. Prüfungen
  •  Klinischer Prüfplan
    • Rationale von klinischen Prüfungen
    • Studiendesign und Definition von Endpunkten

Dieses Seminar / dieser Basiskurs ist Teil unseres Online-Lehrgangs: Regulatory Specialist für Medizinprodukte und IVD.

Ihre Trainerin

Priv. Doz. Dr. Ghazaleh Gouya Lechner, Expertin für Klinische Prüfungen und Bewertungen, Gouya Insights GmbH & Co 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 ein Teilnahmezertifikat.
  • 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. 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

Basiskurs: Anforderungen & Prozesse für die Entwicklung von Medizinprodukten & IVD

in , , , , ,

Dieser Basiskurs gibt Ihnen einen Einblick in regulatorische Anforderungen und Prozesse zur erfolgreichen Entwicklung von Medizinprodukten und In-vitro Diagnostika. Welche Elemente müssen Entwicklungsprojekte enthalten, damit Zeit- und Kostenrahmen eingehalten werden und die regulatorischen Anforderungen von Anfang an berücksichtigt werden?

TeilnehmerInnen

Dieser Basiskurs ist auch für Teilnehmer:innen ohne Vorkenntnisse oder mit geringen Vorkenntnissen geeignet. Sie benötigen für die Teilnahme an diesem Seminar allerdings Erfahrung mit (Medizin-) Produktentwicklung.

Die Seminar-Inhalte

Regulatorische Anforderungen

  • EU-Verordnungen für Medizinprodukte und IVD
  • Global: The GHTF Regulatory Model
  • USA: FDA – QSR: Design Controls

Prozesse für die Medizinprodukt-Entwicklung

  • Projektmanagement
  • Qualitätssicherung in der Entwicklung
  • Teilprozesse für den Entwicklungsablauf
  • Von Anforderungsmanagement zum Designtransfer
  • Unterstützende Entwicklungsprozesse
  • Wo gibt es Unterstützung, nützliche Quellen und Websites?
  • Do’s and Don’ts – ungeschriebene Gesetze
  • Erfahrungsberichte: Gebrauchstauglichkeit, Prozessvalidierung

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 Teilnahmezertifikat
  • 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

Online-Forum Roundtable: Regulatory Update für Medizinprodukte & In-vitro Diagnostika

in , , , ,

Aktuelles und Best Practice aus den Bereichen

Regulatory Affairs und Qualitätsmanagement

für Medizinprodukte und IVD

 

Gemeinsam mit den Clusterorganisationen Standortagentur Tirol, LISAvienna, Human.technology Styria, Medizintechnik-Cluster Oberösterreich, ecoplus Niederösterreich und Innovation Salzburg erweitern wir wieder die regionalen „MDR Stammtische“ zu einem österreichweiten Online-Forum Roundtable.

In dieser Cross-Cluster-Veranstaltung wollen wir Ihnen wieder ein Regulatory Update zu speziellen Themen der MDR-IVDR geben.

Neben den Expertenvorträgen und Praxis-Beispielen gibt es daran anschließend wieder die Möglichkeit für individuelle Fragen!

Programm

  • 16:00 Updates aus den Bundesländern
    Life Science Cluster Austria
  • 16:10 Nachhaltigkeit in der Medizintechnik
    Laura Daviña König, Human.technology Styria
  • 16:20 Digitale Gesundheitsanwendungen DiGA – aktuelle rechtliche Entwicklungen
    • Dr. Gisela Ernst: Rechtswissenschaftlerin mit Schwerpunkt Medizin- und Gesundheitsrecht an der Universität Wien
    • Dr. Ingrid Jez: Juristin mit Schwerpunkt im Medizin- und Gesundheitsrecht (inkl Datenschutzrecht)
  • 16:45 Safety vs. Security – eine Risikobetrachtung
    Volker Sudmann, Niederlassungsleiter austria, mdc medical device certification
  • 17:10 Update zu UDI & EUDAMED
    Poppy Abeto Kiesse, Business Development Manager Healthcare, GS1 Austria
  • 17:40 Q & A

Veranstaltungsort: ONLINE

Das Online-Forum ist kostenlos.

Hier geht’s zur Anmeldung

LISAvienna Regulatory Affairs Conference for Medical Devices and In-Vitro Diagnostics

in , , , , , , ,

LISAvienna cordially invites you to attend the ninth Regulatory Affairs Conference for Medical Devices and In Vitro Diagnostics, taking place on October 15, 2025, in Vienna. We – en.co.tec – are happy to be part of the organization and program planning team!

Look forward to a day filled with expert presentations, interactive discussions, and practical insights into all aspects of market authorization, along with the latest updates on MDR, IVDR, and other relevant regulations. Take advantage of this opportunity to stay informed and expand your professional network.

Register now to secure your spot and join us for an unforgettable experience at a fantastic venue, Apothekertrakt, Schönbrunn Palace!

This year, the talks will be held in English. Registration for the 9th conference is now open.

What’s new?

  • The conference will be conducted in English to accommodate our growing international community.
  • A professional partnering tool will enhance strategic networking, especially for start-ups and newcomers.
  • A revised session format: 3 x 3 parallel sessions instead of 2 x 5, allowing participants to attend more discussions.
  • A small conference fee will be introduced to help cover rising costs.

What stays the same?

  • Inspiring keynote lecture.
  • Leading experts from Notified Bodies and Authorities will share their insights.
  • Peers from start-ups, SMEs, industry, consulting and academia will discuss real-world challenges and solutions.
  • Plenty of opportunities for informal networking.
  • A fantastic venue: Apothekertrakt, Schönbrunn Palace, conveniently located next to subway line U4 (Schönbrunn station).

Registration is open: https://www.b2match.com/e/lisavienna-reg25

Conference updates will be tagged with #REG25.

MDR Table: Klinische Daten & Post-Market Surveillance im Fokus

in , , , , , ,

Der steirische Humantechnologie-Cluster lädt zur ersten Ausgabe des MDR Tables im heurigen Jahr – diesmal zusammen mit unserem Geschäftsführer und Experten Martin Schmid (en.co.tec) und Raymond Nistor (Platomics, QMD Services).

Raymond Nistor ist Mediziner, war viele Jahre in leitender Funktion für die Industrie tätig und maßgeblich am Aufbau der österreichischen Benannte Stelle QMD Services beteiligt, wo er den klinischen Bereich verantwortet hat. Zusammen mit Martin Schmid als österreichweit führenden regulatorischen Experten wollen wir unseren Fokus diesmal auf die Bedeutung klinischer Daten richten – von der Entwicklung, Zulassung bis zur Überwachung von Medizinprodukten nach ihrem Inverkehrbringen.

Wir freuen uns auf einen regen Austausch!

Für Verköstigung wird im Rahmen der Veranstaltung gesorgt.

Veranstaltungsort:

Medical Science City Graz
Campus Platz
Meetingraum 87 im Erdgeschoss – oberhalb Cafe Mensa Graz

Veranstalter:

Human.technology Styria GmbH

JETZT ANMELDEN!

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

in , , , , , ,

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.

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: Mastering Medical Requirements Gathering for Successful Product Development

in , , , ,

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

 

Unlock the potential of your medical product development with our comprehensive lecture series on Medical Requirements Gathering. Designed for healthcare professionals, IT specialists, and product managers, our course provides the essential knowledge and practical skills needed to gather, document, and manage requirements effectively, ensuring your medical products meet user needs, regulatory standards, and market demands.

Why Attend Our Lecture Series?

1. Industry-Specific Insights:

Gain a deep understanding of the unique challenges and considerations in the healthcare domain, including patient safety, regulatory compliance, and data privacy.

2. Comprehensive Stakeholder Engagement:

Learn techniques for identifying and prioritizing key stakeholders such as patients, healthcare providers, and regulatory bodies to ensure all critical perspectives are captured.

3. Regulatory and Compliance Mastery:

Navigate complex healthcare regulations like HIPAA, GDPR, and FDA standards with confidence, ensuring your products comply with all necessary legal requirements.

4. Practical Requirements Gathering Techniques:

Master various techniques including interviews, surveys, observations, and workshops to gather precise and actionable requirements directly from your users.

5. Effective Documentation and Management:

Utilize best practices and tools for documenting, managing, and maintaining requirements, ensuring traceability and alignment with project goals.

6. User-Centered Design Principles:

Implement user-centered design methodologies to create intuitive and effective medical products that meet the real needs of end-users.

7. Addressing Challenges and Ensuring Success:

Overcome common challenges such as miscommunication, scope creep, and stakeholder conflicts with proven strategies and best practices.

8. Ethical and Privacy Considerations:

Ensure your products adhere to the highest ethical standards and protect patient privacy throughout the development process.

9. Keeping Up with Emerging Trends:

Stay ahead of the curve with insights into the latest trends and technologies in healthcare, such as AI, IoT, and telemedicine, and their impact on requirements gathering.

10. Hands-On Case Studies and Practical Examples:

Learn from real-world case studies and practical examples that illustrate successful requirements gathering and product development in the medical field.

Why Choose Us?

Our lecture series is tailored to equip your team with the essential skills and knowledge required for successful medical product development. By attending, you’ll ensure your products are user-friendly, compliant, and positioned for success in the competitive healthcare market.
Invest in your team’s expertise and the future success of your medical products. Join us for this invaluable lecture series and transform your approach to medical requirements gathering.

Costs

  • Standard: 395,00 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.

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: Biocompatibility of Medical Device

in , , , ,

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 course: Clinical Investigation – Supporting the Clinical Evaluation of a Medical Device (2 days)

in , , , , ,

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.

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!