• EU MDR and medical device software and software as medical device
    • Regulations, standards and guidance documents
    • European harmonized standards
    • International guidance documents
  • Overview structure EN 62304
    • Scope and Chapter structure
  • Medical device software terminology
    • Medical Device Software (MDSW), Software as Medical Device (SaMD)
    • Terminology EN 52304 clause 3
  • Software lifecycle processes according EN 62304 and EU MDR 2017/745 including testing
    • Regression testing
    • Test methods
    • SOUP
    • CE-Marking
    • EU MDR 2017/745 GSPR
    • EU MDR 2017/745 Annex VIII
    • EN 62304-chapter structure
    • EN 62304 – development process
    • EN 62304 – maintenance process
    • Software safety classification
    • Software lifecycle and risk classes – activities
    • Short outlook to US FDA
    • Software design
    • Unit implementation
    • Integration and Integration testing
    • Testing techniques
    • System testing
    • Software release
    • Software maintenance plan
    • Problem and modification analysis
    • Modification implementation
    • Risk management
    • Software configuration
    • Change control, records and trends
    • Interface to EN 60601-1
  • Artificial Intelligence (AI) & Machine Learning (ML)
    • AI and ML under EU MDR 2017/745 and US regulation, approach for registration process

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Frank Stein

Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

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$699.00

(One Dial-in One Attendee)

(After registration, we will video stream the training on your convenient dates)
Last Recorded Date: July 27, 2022

$4,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training on your convenient dates)
Last Recorded Date: July 27, 2022



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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
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