Register a second person and receive 5% off of your total course-fee immediately!
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.
Audience
Anyone interested in regulatory expectations and requirements regarding Medical Devices
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 699
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Networking
✓ Course certificate after completion
Location
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Your Trainer
Kristina Bindus
-
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.
- Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program
General Introduction to Medical Devices
-
Applicable European and Belgian legislation
-
Definitions
-
Classification
-
CE marking
-
ISO 13485
-
Competent Authorities: how to handle an inspection
Distribution and export
-
Notification of distribution
-
Export certificate and application procedure
-
Fees and payments
Good Distribution Practice
-
Guideline
Workshops
-
Exercise 1: Classification of Medical Devices
-
Exercise 2: Inspection
Good Distribution Practices (part II)
-
Quality system: minimum requirements
-
Practical implementation
Materiovigilance
-
What needs to be notified, by whom and how?
Electr(on)ic Medical Devices
-
Applicable legislation
-
Bebat
-
Recupel
Participants about this course:
Date
Date 1
Date 2
Date 3
Contact Quastion for more information about this Medical Devices: General Rules and Practices training.
Not available on this date?
You can always contact us for a course on demand
Do you prefer to send an offline signup form via mail?
Download it
full
full
full
Heading 6
You are signing up for:
Medical Devices: General Rules and Practices
date
hhmm
- hhmm
Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Please fill in your info below
1. Company details
Company name *
Enter a company name
VAT-number *
Enter a valid VAT-number
Address *
Enter an address
City *
Enter a city
E-mail address *
ZIP code *
Enter a ZIP code
Country *
Enter a country
Enter a valid e-mail
2. Participants
Select the number of participants:
Alert number
Since we provide a lunch, please inform us of any food allergies or restrictions:
1
First name *
Enter a name
Last name *
Enter a name
Possible food allergies or restrictions
2
First name *
Enter a name
Last name *
Enter a name
Possible food allergies or restrictions
3
First name *
Enter a name
Last name *
Enter a name
Possible food allergies or restrictions
4
First name *
Enter a name
Last name *
Enter a name
Possible food allergies or restrictions
5
First name *
Enter a name
Last name *
Enter a name
Possible food allergies or restrictions
3. Discount Code
I have a discount code
Your code has been accepted!
Code is not valid has been used already
€ discount per participant is applied.
4. Price calculation
Price per participant
Number of participants
Total price
€ 699
(excl. VAT)
€ 699
discount applied
1
€ 699
€ 699
(excl. VAT)
If you use the KMO-portefeuille:
(Check if your company is qualified to use this)
€ 699
(excl. VAT)
incl. 5% promo discount
discount applied
Please check this box
* I accept the Terms of Use and the Privacy Policy.
I want to receive the newsletter.
4. Payment
€ 699
Total amount:
Choose your preferred payment method
You will receive a confirmation about your signup after the online payment is completed.
We will send you our account information so you can transfer the money when it suits you best.