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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and requirements for Medical Devices. The course aims to provide you with the guidance and tools to understand and implement the regulatory requirements for Medical Devices in your daily activities.
Anyone interested in regulatory expectations and requirements regarding Medical Devices
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Course certificate after completion
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
Kristina is specialized in online medical communication: webcast, webinar and e-learning.
She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
Kristina has an extensive experience in Quality & Pharmacovigilance.
General Introduction to Medical Devices
Applicable European and Belgian legislation
Competent Authorities: how to handle an inspection
Distribution and export
Notification of distribution
Export certificate and application procedure
Fees and payments
Good Distribution Practice
Exercise 1: Classification of Medical Devices
Exercise 2: Inspection
Good Distribution Practices (part II)
Quality system: minimum requirements
What needs to be notified, by whom and how?
Electr(on)ic Medical Devices