References

Major Medical Device manufacturer:

2017 – Ongoing Accountable project manager MDR (EU) UDI Project. Startup phase, including early stage investigation, initial scoping and brief description 2018 – MDSAP Lead Manufacturing Site Audit
2014-2016 Accountable project manager FDA UDI Project and all aspect of the implementation. Including early stage investigation, initial scoping and brief description, setting up project governance, budget, regulatory interpretation, implementation of GS1 standards, implementation of data and upload system to GUDID, update and implementation of global label print system, SOP and guideline updates and all other aspect in a major regulatory implementation project. Balancing organizational fit within IT-, operational/supply chain- and regulatory strategy. Please contact us for direct references.
 
2015 – 2016 Accountable for full FDA readiness in the design transfer area, responsible for all process and SOP updates preparing for first FDA inspection in major Medical Device company.
 
2013-2015 NPI Project Manager for new Medical Device releases
 

Other

2010-2013 Accountable Project Manager developing and implementing innovative automation/robot solutions streamlining major companies processes in various industries.
 

Speaker at: 

 
UDI and Traceability Amsterdam (IQPC) – https://www.udisandtraceability.com/ (2018)
 
Make Medical Device Creation Easier Turning regulatory complexity to a competitive advantage 
 
http://go.techniatranscat.com/de/veranstaltungen/make-medical-device-creation-easier- Zürich (2018)
 
UDI and Traceability Brussels (IQPC) – https://www.udisandtraceability.com/ (2017)
 
Make Medical Device Creation Easier – http://go.techniatranscat.com/make-medical-device-creation-easier (2016)
 

Network Groups

 

Medico Industrien (Danish) Network groups: Packing, UDI, Medico/Healtcare Consultants