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James joined Advena as the Medical Device Quality Management Consultant/Manager. He has 25 years broad experience in Quality Assurance and Regulatory Affairs, which he gained working in Medical Device manufacturing (Class I to Class III) and whilst working for a leading Notified Body. He is well positioned to support Advena clients establish and maintain compliant Quality Management Systems. Also an IRCA Certified ISO13485 Lead Auditor, James can identify compliance risks and areas for improvement that support the client business goals, and conformity to relevant requirements.

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