Workshop "Mastering structured data – for medical technology manufacturers and notified bodies"

• Advantages of structured data for regulatory tasks
• YAML files: use cases, creation, validation
• JSON files: use cases, creation, validation
• JSON schema files: use cases, creation, validation
• Reviewing regulatory documents with structured data
• Extracting information from regulatory documents into structured data
• Creation of regulatory documents based on structured data

• Be able to name the advantages of structured data (e.g. in YAML and JSON format) in the creation, review and submission of technical documentation
• Be able to explain the differences, similarities and respective use cases of YAML and JSON files
• Be able to use online validators to check YAML, JSON and JSON schema files for syntactic correctness, understand reported errors and correct them
• Be able to create syntactically correct YAML, JSON and JSON schema files
• Be able to create a suitable JSON file for a JSON schema
• Be able to check your own documents for conformity using AI and YAML and JSON files
• Be able to transfer information from existing documents into a structured format
• Be able to create a document from structured data

The workshop is aimed at employees of medical device and IVD manufacturers as well as notified bodies who create or review technical documentation in accordance with laws and standards:

• Regulatory affairs managers
• Clinical affairs managers
• Quality managers
• Auditors
• Developers who are not familiar with YAML, JSON and JSON schema

Participants can easily follow this workshop even without any special prior knowledge

Please note that, for licensing reasons, we are unable to provide participants with access to the AI tools we use. To actively participate in the practical exercises, you will therefore need to arrange access to at least one of the commonly used LLM chatbots on your own before the session begins.

After registering, you will receive a confirmation email containing the meeting link, the time and information about the participants.

Within the next 48 hours, you will receive an invoice with a payment term of 14 days. If this payment term is not feasible for your company, please send a short email to [email protected] to find a solution.

Three days before the seminar, you will receive two emails: the first will contain the final link to the seminar and the second will contain the access data for a cloud folder where you will find preparation documents, exercises and presentations.

Our online/remote workshops are conducted using the MS Teams video conferencing tool. We recommend that you dial in 20 minutes before the start of the workshop to resolve any technical issues in good time. Our team is available at any time to answer your questions or help with any problems.

At the end of the workshop, you will receive a feedback link for evaluation. We will send you your certificate of participation the following day.

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.