Hello
My name is Kees den Besten, the founder of Medtech Compliance Consult. I help Medtech companies find solutions to complex issues around quality assurance and regulations. I believe that the best solution comes from seeing the connection between quality, regulations, company culture, and business goals. I like to share this insight and how to apply it with others.
resume
My Story
My passion for the medical device industry started at Notified Body KEMA (CE0344) in the Netherlands. As a Notified Body auditor and technical file reviewer, I saw up close how the industry adapted to the then new Medical Device Directive. And although every company ultimately met the same requirements, I found it fascinating to see how big the differences in efficiency, effectiveness and management commitment were between companies. This realization laid the foundation for my further career and the creation of Medtech Compliance Consult.
After five years at KEMA, I have been fortunate enough to hone my quality assurance and regulatory expertise in leadership roles at Medtronic, Cordis, Baxter, HOYA and DORC. In combination with completing an executive MBA, I have developed into a versatile professional with more than 25 years of experience in the medical device industry. For the last 10 years, I have worked at board level in fast-growing global companies.
A common thread throughout my career is the analysis and solving of structural problems in the field of quality assurance and regulatory affairs. In various companies I have successfully implemented permanent improvements in both the organizational structure and the processes. By achieving these results, I am convinced that as a consultant I can help executives and functional leaders in the Medtech industry to achieve similar results.
I am convinced that it is essential to align the quality and regulatory affairs strategies with the business strategy. Only then will business growth be possible without unacceptable regulatory compliance risks. Companies often forget about this crucial alignment; the connection is sometimes not seen, or even deliberately ignored. As a result, sooner or later companies run into compliance problems or end up in a culture where quality assurance and regulations are seen as hindering factors rather than facilitators for growth.
My mission is to show that complex issues in the field of quality assurance and regulations can be solved most effectively with a coherent, business-oriented approach. My strength lies in seeing coherence and the courage to investigate and use the grey areas in the regulations.
Interested? Fill in the contact form, give me a call at +32 470 372 157 or send an email to info@medtechcomplianceconsult.com.