Senior QA Consultant
Ivan Whelan (Bsc Hons MRSB) has worked in pharmaceutical, biotechnology and medical devices sectors for over 20 years and holds a degree and postgraduate in biological sciences. Ivan is also a member of the Royal Society of Biology.
With his extensive industry and business background, Ivan provides practical solutions to any given project or remediation activity. A qualified lead auditor and tutor for the Medical Devices sector, he has tutored courses globally and delivered assessments to multiple jurisdictions and standards.
Ivan has years of hands-on experience with industry standards and regulation, including ISO 13485, ISO 14971, MDSAP, MDR / IVDR 21CFR, CMDCAS , ANVISA, JPAL, Taiwan, TGA , and others.
Prior to forming Meddev Solutions, Ivan led a successful team for a leading European notified body, as well as conducted assessments of QMS for 13485 certification. Ivan is still actively engaged with notified bodies, performing audits on their behalf and providing them with technical expertise.
Ivan is driven to bring conformity to clients issues and concerns through practical, workable solutions.