Regulatory Requirement for Medical Devices / Europe and its application

Operations
Quality
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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
3 days (2 days can be customized)
Course fee
-

Program Description

Topics to be covered with this training includes:

  • Part1: Medical Device GMP (QMS).
  • Part2: MD Classification in Europe.
  • Part3: MD Clinical Trials in Europe.
  • Part4: MD General Requirements in Europe.
  • Part5: CE Marking process and the Regulatory Submission in Europe.
  • Part6: MD Modifications in Europe.

Target Level

  • Graduated pharmacists.
  • Graduated Biotechnology students.
  • Regulatory Affairs specialists and officers in drug stores.
  • Regulatory Affairs specialists and officers in medical devices stores.

Description

Objectives and Expected Results

  • Participants will be introduced to the MD GMP process in Europe.
  • Participants will understand the MD classification rules in Europe.
  • Participants will be introduced to the MD clinical trial process in Europe.
  • The participant will take an idea of the general requirements for the MD CE mark process.
  • Participants will understand the CE marking process in Europe.
  • The participant will take an idea of the MD modification process in Europe.

Others Training Materials

  • The workshop, group work, and discussion question will be conducted during training.
  • YouTube videos.
  • Handout.

Target group

  • -

    Trainer Languages English/Arabic

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232