The Thora Tech Academy

We offer you both individually tailored consulting and support in the development of medical devices, especially in the area of regulatory requirements - as well as the necessary basic knowledge in the form of our certificate training courses.

Individual advice and support

Quality management systems for Manufacturers of Medical Devices (EN ISO 13485)
Implementation of the Medical Devices Ordinance
Risk management for Medical Devices
(EN ISO 14971)
Usability-oriented development process (EN ISO 62366-1)
Electrical safety of medical devices (EN 60601-1)
Programmable Electrical Medical Systems (PEMS)
Software Lifecycle
(EN 62304)
Technical documentation for medical devices
  • Do you have a product idea?
  • Do you need an objective feasibility check of your product idea?
  • Do you need a specialist for the technical implementation of your product idea?
  • Do you need support in creating the technical documentation?
  • Do you need advice on admission?

... in expert discussions we show you the way from the idea to the product!

We work with you to develop an individual concept for the realization of your product specifications.

We help you to observe and comply with the regulatory and normative requirements.

We support you in the implementation of the technical design and the creation of the technical documentation.

We would be happy to provide you with support and handle the overall product development.

Certificate training course

Schulungsplan der Thora Tech Akademie
You will receive the "Manager Regulatory Affairs" certificate upon successful completion of the examination on the contents of the four training courses.

Our training courses

Complete all four courses and receive your own certificate as a
Regulatory Affairs Manager.


Basic I

Basic course Medical Device Regulation MDR

490 385

Duration: 1 Day

  • Current legislative framework for medical devices in Europe (MDR, (EU) 2017/745)
  • Classification of medical devices, conformity assessment procedures, CE marking
  • Basic safety and performance requirements

Basic II

Quality management systems for manufacturers according to ISO 13485


Duration: 1 Day

  • Structure, contents and application of ISO 13485:2016
  • More in-depth knowledge of selected core processes

Advanced I

Risk management for medical devices according to ISO 14971


Duration: 2 Days

  • Requirements of ISO 14971 and their implementation
  • Risk management plan, risk analysis, risk assessment
  • Praxisorientierter Umsetzungsworkshop

Advanced II

Technical documentation for medical devices


Duration: 1 Day

  • Requirements, contents Technical documentation
  • Significance for conformity assessment procedures, notified bodies and authorities
  • Basics clinical evaluation
  • Basics Post-Market Surveillance

Frequently asked questions

How long does the exam take and how much does it cost?

The exam takes about 30 minutes. The examination fee is 70 euros per examinee.

Is there a minimum number of participants for the courses?

Yes! In order for a course to take place, at least five participants must be registered per course.

How / Where do the trainings take place?

The training courses can take place as in-house training courses both online or in presence, if the hygiene measures ensure the safety.

An in-house training course is an instrument of company training in the context of personnel development. Employees receive a customized in-house course taught by external instructors.

Who holds the trainings?

The trainings are held by our employee / consultant Prof. Dr. Michael Scholtes.

Professor Dr Scholtes works full-time at the Technischen Hochschule Mittelhessen, where he holds the professorship for Digital Medicine with a focus on Regulatory Affairs.

Contact us

You would like to request a consultation / training without obligation or have general questions? Please do not hesitate to contact us!

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