Basic-course: AI-BASED MEDICAL DEVICES and IVD: Navigating European Regulations MDR and IVDR

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AI is reshaping the future of medical technology-but how do you stay compliant in a rapidly evolving regulatory landscape? Europe applies one of the world’s most comprehensive frameworks to guarantee the safety, performance, and transparency of medical devices and IVDs, especially those powered by disruptive technologies like AI.

By the end of this seminar, you will have essential insights into MDR, IVDR, and the latest guidance on AI integration. Learn how to align your innovation with EU expectations, avoid regulatory pitfalls, and accelerate your path to market.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Regulations for AI-based Medical Devices and IVD in Europe

  • Overview of the most important concepts and terms in AI
  • Regulations in Europe
    • EU-Regulations for medical devices (MDR) and In-vitro Diagnostics (IVDR),
    • EU-AI-Act: Harmonized rules for placing AI systems on the European market
    • ISO 13485 – Quality management systems for medical devicessystems – Requirements for regulatory purposes
    • IEC 62304 – Software life cycle processes for medical device software
    • MDCG – Practical guidance documents from the Medical Device Coordination Group
    • IMDRF – International guides for global harmonization of medical device regulations
    • IG-NB – Structured questionnaire for assessing AI in medical devices, aiding notified bodies’ evaluation
  • Exercise:
    • Regulatory documentation assessment using the IG-NB questionnaire

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

  • Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
  • Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
  • incl. seminar documentation as PDF and certificate of participation
  • All seminar discounts at a glance

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

Basic course: Risk management for medical device software according to ISO 14971

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This seminar will be held in English.

Medical device software (stand alone, mobile medical apps, web applications) or software that is integrated into medical devices (firmware, embedded software) must be designed to ensure reliability and performance in accordance with its intended use. According to the EU MDR / IVDR regulations, risks must be eliminated or minimized as far as possible without worsening the risk-benefit ratio.

The establishment of an interactive risk management process over the product life cycle is indispensable for every manufacturer of medical devices. It is important to observe legal requirements and applicable standards. Especially for medical device software, additional requirements are imposed, e.g., effects of software errors, negative interactions, aspects of the IT environment and IT security, safety-relevant functions. The overall risk assessment in the context of the verification and validation steps poses major challenges for manufacturers of medical device software.

In this seminar, you will learn the basic requirements for risk analysis for medical software according to the applicable standards, be able to perform a risk analysis and document the results properly. You will be able to evaluate risks in your software and create a risk management report based on this.

Participants:

This basic course is also suitable for participants with no or little previous knowledge. For industry career changers and start-ups, this course offers an optimal introduction to the topic of risk management for medical device software.

This basic course is part of our online course: Medical Software Specialist!

Seminar contents:

  • Risk management basics, definitions of terms
  • Risk management process and ISO 14971
  • Risk Management Analysis, Documentation Requirements
  • Risk analyses for software (Scenario Based Risk Analysis, software architecture, root-cause analyses, FTA, FMEA, third-party components, concepts of IEC/TR 80002-1)
  • Risk assessment and risk management report
  • Production and post-production activities, (configuration management, deployment, updates of databases, operating systems, etc.)
  • Change management and risk
  • Normative requirements (EN ISO 14971:2019/A11:2021, references of ISO/TR 24971 and IEC/TR 80002-1:2009 ,… etc.)

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, 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 documents as PDF and a certificate 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. 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

Basic course: ISO 14971:2019 – Risk management for medical devices & IVDs

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Safety is the top priority for medical devices. The systematic analysis and verifiable reduction of risks is therefore a fixed component of legal and normative requirements.

In this seminar, you will learn how to quickly and easily implement the risk management requirements for risk management according to ISO 14971:2019 in your company quickly & easily.

Seminar contents

  • Requirements of the EU regulations (MDR / IVDR) and the quality management standards for risk management
  • Risk management according to ISO 14971:2019
  • Implementation and documentation of risk management with the en.co.tec toolbox:
    – Risk management plan
    – Risk management file
    – Risk management report
  • Exercise example risk management file

Participants

This basic course is also suitable for participants with little or no prior knowledge. This course offers an ideal introduction to the legal framework for the risk management of medical devices and in-vitro diagnostics for industry newcomers and start-ups.

Your trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs

  • Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
  • Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
  • incl. seminar documents as PDF and a certificate of participation.
  • All discounts at a glance

Venue: ONLINE

All you need for our ONLINE seminars is a laptop with a camera and microphone. Our eLearning platform works on all operating systems in a web browser. You will receive the seminar documents and the link to the virtual seminar room by email in good time. 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 exercises and also the opportunity to exchange ideas with the other participants.

Click here for your online registration!

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

Basic course: UX and Usability for Medical Software and Apps according to IEC 62366-1

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In this hands-on training, you will learn how to implement user experience (UX) and usability for medical software.

This starts with the topic of user research, in order to understand who the users of the software are and in which environment the software is used. If the user has to pick up the phone again and again, even though this would only be necessary at the end, then the context has not been properly understood. This can be done with systematic UX and usability methods.

Then usage requirements are defined and, for medical devices, usage errors are passed through the interface to risk management for evaluation.

This is followed by the translation into a design solution including the risk control measures. Since human behavior is not easy to predict, the design solutions are then evaluated. This can also be done by experts, but tests with users, called usability tests, are the decisive factor.

For medical software and apps, IEC 62366-1 must be met in Europe. In the USA, an FDA guidance document entitled “Applying Human Factors and Usability Engineering to Medical Devices” applies. Here, usability testing is required at the end of development. The corresponding telemetry data of the software can be used for market monitoring.

These activities require a good understanding of UX and usability engineering which we will provide you with in this seminar.

SEMINAR CONTENT

  • Legal basis according to MDR and IVDR
  • Norms and standards esp. IEC 62366-1:2015+AMD1:2020
  • Integration of usability engineering into risk management
  • Integration of usability engineering into development
  • User Research as the basis of the Use Specification according to IEC 62366-1
  • Use Scenarios, Critical Tasks and Analysis of Use Errors
  • User Interface Specification and pragmatic creation of requirements for the user interface
  • Formative evaluation for the improvement of prototypes
  • Summative evaluation for the validation of risk control measures
  • Usability Engineering File and Human Factors Engineering Report

PARTICIPANTS

This basic course is also suitable for participants with no or little previous knowledge. For industry career changers and start-ups, this course offers an optimal introduction to the topic.

This basic course is part of our online course: Medical Software Specialist!

YOUR TRAINER

Dipl. Inf. (FH) Michael Engler, Senior Consultant, Managing Director at EMPIANA GmbH

COSTS

  • Early bird (until 4 weeks before the seminar): Euro 540,- (excl. VAT)
  • Standard (starting 4 before the seminar): Euro 610,- (excl. VAT)
  • All seminar discounts at a glance
  • incl. seminar documents as PDF and a certificate of participation

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 questions: office@encotec.at or +43 1 8863491

Seminar: General safety and performance requirements for medical devices and IVDs

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The general safety and performance requirements of the new EU regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) are the basis for a conformity assessment procedure. Manufacturers primarily use harmonized standards to demonstrate conformity with these requirements. This can be done efficiently using checklists with the relevant standards.

This seminar provides an overview of the general safety and performance requirements according to MDR and IVDR. Using a detailed checklist, the two trainers will show you which harmonized standards must be complied with for your product and how to apply them.

Participants

This seminar is NOT suitable for participants without prior knowledge. You will need basic knowledge of the conformity assessment procedures and the preparation of technical documentation for medical devices and / or IVDs.

The seminar contents

  • Overview General Safety and Performance Requirements
  • GSPR for medical devices
  • GSPR for in-vitro diagnostics
  • Overview of the requirements of the relevant standards
  • Methodology & checklists
  • Exercise examples

This seminar / basic course is part of our online course: Regulatory Specialist for Medical Devices and IVD.

Your trainers

  • Marie Salin, Managing Director, West Medica Produktions- und Handels-GmbH – experienced regulatory expert for IVD, consultant, trainer and certified internal auditor
  • DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs

  • Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
  • Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
  • incl. seminar documents as PDF and certificate of participation
  • All discounts at a glance

Venue: ONLINE

All you need for our ONLINE seminars is a laptop with a camera and microphone. Our eLearning platform works on all operating systems in web browsers (e.g. Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room by email in good time. 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 exercises and also the opportunity to exchange ideas with the other participants.

Click here for your online registration!

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

Basic-course: AI-BASED MEDICAL DEVICES and IVD: Post-Market Surveillance & Change Management

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Stay compliant. Stay in control – beyond market launch. AI doesn’t stop evolving after approval – and neither should your regulatory strategy. This compact seminar gives you the essential tools to manage Post-Market Surveillance (PMS) and Change Management for AI-based medical devices and IVDs under EU MDR/IVDR and the upcoming EU AI Act.

Learn how to monitor real-world performance, manage AI model changes (including re-training and change notifications), and fulfill your reporting obligations. Gain clarity on your interactions with notified bodies and regulatory authorities – and ensure your AI-powered products remain safe, effective, and market-ready.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Post-Market Surveillance and Change Management for AI-based Medical Devices and IVD

  • Post-Market Surveillance and Change Management acc. to EU AI Act and MDR/IVDR
  • Monitoring and assessing risks after market launch
  • Dealing with changes to the AI model (change notification, re-training),
  • Reporting obligations and interaction with notified bodies and authorities

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

  • Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
  • Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
  • incl. seminar documentation as PDF and certificate of participation
  • All seminar discounts at a glance

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

Basic-course: AI-BASED MEDICAL DEVICES and IVD: NIS2 Requirements and ISO 27001

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Information Security, Cybersecurity & Data Protection – Achieve Compliance Successfully!

Artificial intelligence (AI) has transformed the landscape of medical devices and in vitro diagnostics (IVD), ushering in new opportunities and challenges for healthcare innovation. As these technologies become increasingly integrated into critical healthcare infrastructure, it is essential for professionals to understand the evolving regulatory and cybersecurity landscape.

Not every manufacturer is necessarily considered the provider of a high-risk AI system. Many medical device manufacturers use large language models (LLMs) from different vendors for their software development. As a result, companies assume various roles and responsibilities under the Medical Device Regulation (MDR) and the AI Act.

This introductory course provides a comprehensive overview of the fundamental requirements for AI-based medical devices and IVDs, with a focus on compliance with the NIS2 Directive and ISO 27001 standards.

In this seminar, our expert expertly illustrates the interconnections between MDR, the AI Act, and the NIS2 directive. Using best practice examples – especially from ISO/IEC 27001 certification – he demonstrates actionable solutions. Data protection, as an essential aspect, is also thoroughly addressed.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

NIS2 Requirements and ISO 27001 for AI-based Medical Devices and IVD

  • Requirements for information security, cybersecurity and privacy protection
  • Implementation of information security management systems
  • NIS 2 Directive – cybersecurity risk-management and reporting obligations
  • Implementing a compliance strategy within the fields of medical devices, information security, artificial intelligence and data protection

Your Trainer

  • Dr. MMag. Markus Speiser: As a doctor of law, trained business economist, project manager, and data protection officer, I support economic actors in this very exciting environment so that they can bring medical devices to market. https://www.linkedin.com/in/markus-speiser-b362b11ba/

Costs:

  • Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
  • Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
  • incl. seminar documentation as PDF and certificate of participation
  • All seminar discounts at a glance

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

Online Forum Roundtable: Regulatory Update for Medical Devices & In-vitro Diagnostics

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News and best practice from the following areas

Regulatory Affairs and Quality Management

for medical devices and IVD

 

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

In this cross-cluster event, we would like to give you a regulatory update on specific topics of the MDR-IVDR.

In addition to the expert presentations and practical examples, there will again be an opportunity for individual questions afterwards!

Program

  • 16:00 Updates from the federal states
    Life Science Cluster Austria
  • 16:10 Regulatory Update
    Martin Schmid, en.co.tec
  • 16:20 Funding meets regulation: building bridges for DeepTech innovations
    Regina Weinmüllner, AWS
  • 16:45 Best Practice: Lines of Code, Layers of Regulation – ESD’s path to MDR certification
    Yvonne Rauner, ESD
  • 17:10 tbc
  • 17:40 Q & A
  • more program details will follow soon!

Venue: ONLINE

The online forum is free of charge.

Click here to register

Basic-course: AI-BASED MEDICAL DEVICES and IVD: Mastering Risk Management

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Unlock the future of healthcare: Artificial Intelligence is transforming diagnostics, robotics, and personalized medicine-but innovation brings new risks. Join our exclusive seminar to discover cutting-edge strategies for navigating the unique challenges of risk management in AI-powered medical devices and IVDs. Ensure regulatory compliance, protect patients, and lead your organization confidently into the next era of medical device software technology.

By the end of this seminar, you will have gained an overview of the global requirements for risk management of AI-related medical devices and IVDs. You will also develop practical skills in risk assessment and mitigation, ensuring compliance and successful market access for AI-powered health technologies.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Risk Management for AI-based Medical Devices and IVD

  • Risk management basics, definitions of terms
  • Risk classification according to EU AI Act and MDR/IVDR
  • Relevant standards:
    • ISO 14971 (general risk management),
    • AAMI/BSI TR 34971 (AI-specific risks),
    • IEC 62304 (Risk management in the software life cycle)
  • Special requirements and challenges:
    • Data management: selection, anonymization, quality and representativeness of training data, validation and verification of AI models (e.g. robustness, generalizability),
    • Dealing with adaptive and learning systems (continuous learning),
    • Human oversight: mechanisms for human control and intervention options
  • Exercise:
    • Create a risk matrix for an AI diagnostic tool: Participants analyze a fictitious AI-based diagnostic system, identify possible risks (e.g. incorrect classification, data bias) and evaluate these together in a risk matrix.

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

  • Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
  • Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
  • incl. seminar documentation as PDF and certificate of participation
  • All seminar discounts at a glance

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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

Basic-course: AI-BASED MEDICAL DEVICES and IVD: Navigating FDA Regulations

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AI-driven innovation is transforming U.S. healthcare-from diagnostics to personalized medicine. But with this progress come high regulatory expectations. The FDA’s latest guidances outline clear pathways for managing AI across the product lifecycle, including how to implement algorithm changes using Predetermined Change Control Plans (PCCP).

Learn how to get a global overview of AI-related requirements in the US regulatory landscape for medical devices and IVDs. You will gain practical skills to assess technical documentation, ensuring both compliance and successful market access of AI-powered health technologies.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Regulations for AI-based Medical Devices and IVD in USA

  • Overview of the most important concepts and terms in AI
  • Regulations in USA
    • FDA Guidance on AI-Enabled Medical Devices
    • ISO 13485 – Quality management systems for medical devicessystems – Requirements for regulatory purposes
    • IEC 62304 – Software life cycle processes for medical device software
  • Exercise:
    • The participants receive a fictitious AI product and work out which FDA requirements must be met. They create a checklist of the necessary documents (e.g. risk assessment, validation data, Predetermined Change Control Plan).

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

  • Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
  • Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
  • incl. seminar documentation as PDF and certificate of participation
  • All seminar discounts at a glance

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

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