Medical devices & ISO14155
- What is a medical device?
- What is needed to put a medical device on the market?
- Why is clinical research performed with medical devices?
- Which laws and regulations apply to medical devices?
- What will change with the arrival of new legislation and regulations regarding medical devices in the EU?
- What are the differences in conduct between drug studies and medical device studies?
These are important issues to which I will provide answers in the most practical way possible. So that after following this training you have not only obtained the answers, but through exercises and practical examples, you are also able to apply the acquired knowledge and translate it into practice, tailored to your situation.
After this training you will be able to:
- To indicate when something is a medical device or not
- Identify the individual ingredients needed to place a medical device on the market
- Identify the applicable laws and regulations for medical devices
- Mapping the changes that the new legislation and regulations for medical devices will entail
- Identify the differences in conduct between drug studies and medical device studies
Register for this training
By clicking on “register” below, you will see the training dates.
You can enter your details by clicking on the available date.
After receiving your payment, you are registered, and you will immediately receive the invoice.
Time: 1 full day from 9:30 a.m. to 4:30 p.m. incl. lunch
Target group: this training lays the foundation for manufacturers and professionals who engage in clinical research with medical devices, and already have experience with ICH-E6 (R2) Good Clinical Practice
Price: €495,- excluding VAT, per participant
Number of participants: min. 6, max. 12
Certificate: certificate of participation
Location: Utrecht region, the Netherlands
Language: the training is provided in Dutch or English. Please indicate in advance if you require the English-language version of the training. The course material is in English.