Michael Schaefer, Freelancer und Technischer (Ghost-)Writer

As a mechanical engineer by training, I have been working in the medical device field since 2001. After initial steps in the production of balloon catheters and heart stents, I took on responsibilities in quality management, process validation, and the introduction of Six Sigma methods in the development and manufacturing of drug-eluting stents — both in Germany and Ireland.

Leading global Pre-Production Quality and Regulatory Affairs for dialysis disposables gave me deep insights into communication and collaboration with authorities and notified bodies. By connecting regulatory requirements for worldwide approvals with quality management tools, I was able to significantly shorten registration times while improving compliance with international standards and regulations.

As Quality Director in a high-volume production of urology catheters and airway management products, I spent three years making decisions, solving problems, and simplifying quality processes. Designing quality management to be both compliant and value-adding is probably one of my greatest achievements.

Since 2014, I have been working freelance and have gained extensive experience both consulting companies and as an auditor for notified bodies.

What matters most to him as a speaker:
My philosophy is to train, establish, and live robust and sustainable quality management systems — with risk management and quality engineering serving as the bridge between development, production, and post-market surveillance. In my trainings, I use practical examples to effectively transfer my experience into participant knowledge.