Beat Steffen confinis ag Hauptstrasse 16 CH- 3186 Düdingen phone: +41 26 494 8 494 mobile: +41 79 297 86 38 email: beat.steffen @confinis.ch web: www.confinis.ch Profile Education Auditor for ISO 13485, annex certificates to MDD 93/42 as well as CMDR (Canadian Medical Device Regulation) Executive MBA in Leadership and Strategic Management Post Diploma in Business Administration - Focus on Project Management and Services Master of Science in Electrical Engineering Apprenticeship as an electro-technician

Professional Experience:

• Managing Director and Partner at confinis ag
• Chairman of the Board of a Pension Fund
• Head of Project Management - built-up and spear-headed project management department in a public medical device company
• Senior Project Manager (new product development) in a public medical device company
• hard- and software development for medical devices

Seats and other Activities:

• Auditor for ISO 13485, annex certificates to MDD 93/42 as well as CMDR (Canadian Medical Device Regulation) for a Notified Body
• Lecturer (Berne University of Applied Sciences): Master of Advanced Studies in Medical Technology / Master of Advanced Studies in Medical Informatics: lecturer for product development according to ISO 13485, software development life-cycle (IEC 62304), and qualification & validation (GAMP 5, 21 CFR Part 11)
• Swiss Delegate, ISO committees TC 76 (transfusion, infusion and injection equipment for medical and pharmaceutical use), TC 84 (devices for administration of medicinal products and intravascular catheters) and TC 210 (Quality management and corresponding general aspects for medical devices)

Languages

• German, English, French, Italian