Template

Training Record

Sven Piechottka · ISO 13485 Templates · Published June 09, 2022

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1. General Information

Name of Training
Date of Training
Training Method
Trainer
Content

2. Participants

No. Name Signature Successful
1
2

3. Confirmation

Hereby, the training supervisor confirms the successful completion of this training for all participants as
indicated in the table above.

Action Name Team / Role Date Signature
Confirmation

4. Evaluation

To be applied after training which has no included effectiveness check (e.g. electronic test): assessment of
effectiveness should be typically carried out by a supervisor. By derogation, a self-assessment is possible,
provided that no second person can adequately evaluate the effectiveness.

Action Name Team / Role Date Signature
Review
Aspect Objectives (largely) not achieved Objectives partially achieved Objectives (largely) achieved Commentary
Applicability and practical relevance
Comprehensibility
Depth

[ ] The training has sufficiently achieved the objective. No further actions are necessary.

[ ] The training has not sufficiently achieved the objective. The following actions are proposed.

Actions:


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Sven Piechottka

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

 I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.
More about me