Lauren Devlin Email & Phone Number

I have worked for Randox Laboratories since I graduated from Queen's University Belfast in 2009.Since then I have worked within several departments for the company (Regulatory Affairs, Applications - IFU management, R&D and RIQAS - External Quality Assessment Scheme) and have gained knowledge and appreciation for various ISO standards such as ISO13485:2016, ISO15189:2012 and ISO17043:2010. I have been involved in many processes of these by registering products internationally, writing IFUs (to IVDD 98/79/EC and now IVDR 2017/746 standards), design control, device verification and validation, compiling information and writing reports for accreditation and providing customer and technical support both to internal staff and external customers. Taken part in internal and external audits, completed CAPAs including relevant risk reports, approve risk reports (which meet ISO 14971).I currently manage a great team of 4 staff ensuring the IFUs contain all the correct information and are available and accessible to customers. We work very closely with Regulatory Affairs, Quality Assurance, Quality Control and Technical Support.