Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Søren is IRCA certified lead auditor of the ISO 13485 standard and have a long experience with sourcing and supplier management activities.
Søren has a background as Toolmaker and Mechanical Engineer which gives him a practical and pragmatic “angle” on the different quality and authority challenges in the medical device world. Søren has more than 12 years “hands-on” experience with filing of medical devices in both EU and US.
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