Markus Bütler, Executive Master Business Excellence FH HSLU

25+ Jahre Erfahrung im Bereich Business Excellence in der Medizin-Produkte Branche. Qualitätsmanagementsysteme nach ISO 13485, ISO 9001, Medical Device Regulation (MDR), Medical Device Single Audit Programm (MDSAP)

Projekte im Regulatory Affairs, FDA 510(k),CFDA, TGA, Health Canada etc.

Bewertung und Entwicklung von Lieferanten im Bereich Medizintechnik, Durchführung von Audits und Remediation Programmen bei Partnern.  

Markus is a QA/RA professional in the medical device industry since over 25 years. His expertise includes Business Excellence in manufacturing, Quality Management System according ISO 13485 certification to obtain CE Marking, GMP 820, CMDCAS and MDSAP. He also specialized in Regulatory Affairs, Product registration at FDA, CFDA, TGA, J-PAL and others.

He holds a degree of Master of Business Excellence, FH HSLU (Luzern)

CQI and IRCA Certified Quality Management Systems Lead Auditor Training (incorporating ISO 13485:2016 and MDSAP Requirements (Oct.2017) and some MDR 2017/745 trainings.