Rod has worked in Pharmaceutical and Medical Device sectors for over 20 years and holds a degree in engineering. Rod has earnt Global Regulatory Affairs Certification from the Regulatory Affairs Professional Society.
His expertise lies in providing regulatory guidance to support new product development, worldwide registration and compliance activities. Rod is able to train large groups in the global regulatory requirements as well as QMS.
He has years of hands-on experience of industry standards and regulation such as ISO 13485, ISO 14971, ISO 10993, IEC 60601-1, IEC 62304, IEC 62366, MDD 93/42/EEC, 21CFR, CMDCAS (MDSAP) amongst others.
He has registered devices in over 30 countries including EU, US, Canada, Japan, China, Russia, Kingdom of Saudi Arabia, South Korea and Latin America.
Prior to forming Meddev Solutions, he was a Client Manager for a leading European Notified Body, conducting assessments of QMS for 13485 certification. Rod is still actively engaged with Notified Bodies, performing audits on their behalf and providing technical expertise.
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