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Medical Devices: General Rules and Practices

1 Day
Life Sciences

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.

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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
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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 Small.jpg

    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

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Medical Devices: General Rules and Practices

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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