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We recently had some Technical Files (class IIa and IIb) audited (on site) by NB auditors. Now in the TF review report the auditors positions are described as “Technical Expert”. However, they clearly had no practical expertise with the actual products; though they had a regulatory background, and only appeared to appraise them clause by clause against the relevant standards. So what defines a “Technical Expert”? We have quite a range of products covering about ten different specific standards (including both electrical and non-electrical products) – I am not counting QMS, risk, usability, electrical safety, labelling etc. related ones here. So for example how could you be an expert in say wound care products one minute, and then also respiratory systems the next?