Nick Baker, LRQA Technical Manager – IVD Medical Devices
Nick has worked with LRQA for more than 15 years. As LRQA’s Technical Manager for IVD Medical Devices, he is responsible for the evaluation and assessment of technical documentation and certification decisions. He is the Chair of the Notified Body Recommendation Group and a member of Notified Body IVD working group, as well as a speaker at Informa and Q1 conferences on regulatory issues.
With more than 27 years’ experience in Medical Devices, Nick has prior worked as Scheme Manager for IVDs at BSI. He has extensive experience in IVD industry and was responsible at Anagen for managing a laboratory for routine production of hormone immunoassays and for viral immunoassays as a Team Leader at Murex Diagnostics.
Nick has knowledge of clinical chemistry and infectious disease, production and design of immuno-assays, and process validation. He holds a BSc in Biochemistry & Physiology from the University of Westminster and a MSc in Medical Biochemistry from Brunel University.
Ian Carmichael, MSc, FIBMS - IVD Technical Specialist
Ian Carmichael joined LRQA in 2011 as the IVD Technical Specialist. Ian is responsible for managing the batch verification process for high-risk reagents, reviewing Design Dossiers and Technical Files for new products and re-approvals. He is LRQA’s product expert for blood grouping reagents, and specialist reviewer for IVD Directive Annex II List A Reagents, Medical Device Software as well as Blood Glucose Monitoring Systems.
Ian stared his career as a Biomedical Scientist within the NHS and then spent over 20 years in the manufacture of in vitro diagnostic reagents, holding various positions in internationally operating organisations ranging from Quality Control Scientist to Director of Quality and Regulatory Affairs. During this time, Ian has gained a thorough understanding and extensive implementation experience of the regulatory requirements for worldwide registration of Medical Devices.