This module is tailored for individuals seeking proficiency in the regulatory landscape of digital health products. It caters to professionals, including but not limited to:

• Health IT Specialists
• Regulatory Affairs Professionals
• Healthcare Managers
• Health IT project 
• Professionals with an interest in Digital Health Compliance

Upon completion of this module, participants will:

• Gain in-depth knowledge of directives, regulations, and requirements for digital health products.
• Develop the skills to contribute to the transformation of the digital health sector by qualifying health IT as medical devices.
• Learn to prepare clinical evaluation plans, risk management plans, and navigate challenges in obtaining regulatory approval for digital health products.
• Acquire the ability to engage professionally in discussions and knowledge sharing about regulations and directives in the use of health IT solutions.
• Establish proficiency in addressing personal data protection, cybersecurity, and traceability requirements for digital health products.
• Identify risk classifications for digital health products and understand the associated classification requirements.

Seminar and exam dates

Teaching takes place online and at:

AAU SUND
Aalborg University, campus Aalborg East
Selma Lagerløft Vej 249
DK-9260 Gistrup

Precise locations at AAU Aalborg will be announced before the programme starts.

Apart from the tuition fee, other expenses should be anticipated for books, software, travel expenses and accommodation during seminars.

To be admitted, you must possess a bachelor's degree in Health Sciences, Technology, Data Science or related fields (or equivalent qualifications). Additionally, a minimum of two years of pertinent work experience in the industry is required.

Click for further information about admission requirements.

The course accommodates students on a first-come, first-served approach.

Exemption from Admission Requirements
Aalborg University may consider applicants without a relevant bachelor's degree on a case-by-case basis, provided they demonstrate academic qualifications equivalent to a relevant bachelor program.

However, the requirement for relevant professional experience remains non-negotiable.