Having been in the medical device industry for over 25 years, I have gained vast experience in the field of marketing, product & business development, engineering, manufacturing, process technology, quality assurance and regulatory affairs of single-use, reusable and active medical devices.
Currently, I focus on supporting clients in their efforts to align their current EU Medical Device Directive (MDD) compliance to the forthcoming Medical Device Regulation (MDR).
My other interests involve supporting innovative Medtech projects that concern manufacturing, sourcing, outsourcing, QA/RA (QMS ISO 13485/FDA QSR), regulatory approvals (CE/510k); setting up turn key facilities to produce various types of medical devices; and securing venture capital.
Acting as independant consultant for medical device start-up projects and/or interim management positions within medical device operation, regualtory affairs and quality management systems.
My undertakings are geographically targeted to Australia, Europe, Malaysia and Singapore.
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