Bert Degens is a dedicated Quality Professional with a broad and international experience in Quality and Regulatory Affairs. On the compliance side his knowledge and skills include the implementation, improvement and application of quality systems in line with international regulations and standards as well as obtaining market clearance for medical devices to international markets including Europe and the US.
On the improvement side he has hands on experience in organizational analysis (e.g. using the Baldrige model), strategy development and deployment techniques, balanced score cards, project management, problem solving and many more specific tools and techniques.
After working for 5 years in different R&D positions with Océ (a Dutch office automation company), he started in 1991 with Medtronic, a US based major medical device company. During his 13 years with Medtronic he held increasingly responsible positions in quality engineering, project management, operational management and quality management. The areas he worked in include design, manufacturing, distribution and sales of a wide range of – mainly implantable and invasive - medical devices.
As a result he has a broad and at the same time practical, business oriented perspective on challenges in the area of quality and regulatory affairs. For his leadership in driving business process improvement and at the same time achieving exceptional results in complying with FDA regulations, he was rewarded by Medtronic with the "Star of Excellence", a quality award on highest company level.
Bert Degens has a background in Technical Physics and founded Degens Quality Solutions in 2003. Since then he served many different customers in the medical device industry, provided numerous trainings, was a speaker at international conferences and became auditor for a major notified body. His strong believe is that the best way for a company to invest in its future is to add value to its customers. Bert enjoys to be regularly recommended by his customers to other parties, which seems a good indicator that Degens Quality Solutions succeeds to put the above vision into practice.