Celebrating 2025/2026

At the end of the year, I am grateful for the journey: celebrating 30 years in industry, 25 years in medical devices, 15 years as a trainer, and 10 years as an authorized auditor. Thankful for the people, learning, and opportunities along the way.

New trainings available!

My updated training plan is available and I am proud to present some new trainings! Looking forward seeing you in the remaining 2025 and/or new 2026!

New MDSAP website

MUST-READ! The new MDSAP website is available including all relevant documents. Finally you can now access as well the new revision 002 of MDSAP AU P0037.002 NC grading.

Benefit-Risk under MDR 2017/745

Nach einer intensiven Vorbereitung freue ich mich sehr mit der TÜV SÜD Akademie ein neues Seminar starten zu können. Unser Seminar hebt die Nutzen-Risiko-Analyse als Herzstück der Konformitätsbewertung unter der MDR 2017/745 hervor. Obwohl diese Analyse nun als...

Audit hint: impact assessment of changes

Audit hint: Please make sure that you document a proper impact assessment of changes. Especially for design changes you must evaluate, for example, impact to shelf-life, bicompatibility, and sterilization. If you are not able to provide such assessments during the...