MICHAEL SCHAEFER
All Trainings
Continuous learning is key to any expert and specialist. Therefore, trainings and seminars, either in person or online, are an essential part of our medical device industry. Based on my background and experience I might be the right person to support your needs.
Seminars by TUEV SUED
Since 2015 I am giving seminars for TÜV SÜD Akademie for many topics like, but not limited to, MDR, MDSAP, Design Control, Process Validation, CAPA, Risk Management, Internal Audits, Technical Documentation, Labeling, Test Method Validation, and vigilance. So far I gave around 400 seminars. My training plan is being continuously updated, so take a look into it! Seminars are available online or in person. Some dates are scheduled in English language!
Inhouse Trainings
If you are looking for a trainer at your premises you should contact me directly. I could be your trainer onsite or remotely. You will organize location and participants and I will deliver the contents. Based on my skillset I can deliver most of the standard trainings around medical device quality systems, like, but not limited to,
- Design & Development as per ISO 13485:2016 and 21CFR820,
- Equipment Qualification and Process Validation (IQ, OQ, PQ),
- CAPA as per ISO 13485:2016 and 21CFR820,
- Test Method validation,
- Risk management process as per ISO 14971,
- Quality Systems as per 2017/745 (MDR),
- Basics and implementation of MDSAP,
- Internal Audits as per ISO 13485:2016 and 21CFR820.
Choosing me as your trainer for your inhouse events brings the advantage of affordable costs in combination with a maximum of internal confidentiality. If you want to have specific contents, workshops or even effectiveness checks we could compile your own agenda and requirements together. Looking forward to your needs!
Statistical techniques
Sometimes you need to gain a better understanding of statistical sampling plans as described in
- ISO 2859-1, ISO 3951-1,
- ISO 16269-6,
- or for the handling of non-normal data.
I offer a short webtraining of around 90 minutes for these topics. The training is hands-on and based on practical examples and can be delivered anytime and also on short-notice.
Trainings by qtec academy
Starting 2024, I am giving some trainings for qtec academy. Those trainings are focused on short webinars and a new kind of family-friendly part-time events (several evening or week-end sessions instead of full day events). We are starting up with the topics
- MDSAP NC grading system – Better look twice!
- Your pathway to become internal auditor – 5 steps to reach your qualification!
- What if your DHF is missing?
Fachkraft Medizintechnik IHK
Als Medizintechnik-Experte freue ich mich sehr, bei der IHK Reutlingen mitwirken zu dürfen. Ein Hauptaugenmerk wird hierbei auf das Qualitätsmanagement gelegt, zu dem ich wesentlich beitragen darf. Die Zielgruppe variiert von Quereinsteigern mit technischen Grundkenntnissen bis hin zu Fachkräften aus der Branche.
Downloads: Training Plan
Address
Heiligkreuzstrasse 59,
72379 Hechingen Germany