Daniel Gilliland

Principal Design Quality Engineer @Smith Nephew

Accountable for all Design Quality, medical electrical safety (e.g, IEC 60601-1), Medical device software (e.g, IEC 62304), wireless certification (e.g, FCC, RED) and hazardous/restricted substance (e.g, RoHS, REACH) compliance for both new and current Advanced Wound Management product portfolio. Leading clause analysis, interpretation, and implementation with both R+D/Operations. Certification test planning/submission and leadership of related product change activities. Providing support and input into FDA 510(k), ETF (European Technical File) and China submissions. Managing critical relationships with Nationally Recognised Testing Laboratories and other regulatory agencies, including Intertek, UL, TUV. Defining global procedures to aid compliance in both new product design and in-market products. Company rep for MedTech Europe Electrical, Chemical and Environmental working groups. Achievements include; Successfully led all safety/software/hazardous substance compliance to support the launches of o PICO 7, PICO 7Y, PICO 14 o RENASYS TOUCH China submission o LEAF o T.I.M.E clinical decision tool Completed a full program of IEC60••••31 edition (including relevant collateral and supporting standards e.g, IEC60••••11) and IEC60••••24th edition certification, including associated remediation activities to ensure continued ability to supply current products to the European Market beyond 2017. This program of work covered the RENASYS©, PICO© and VERSAJET© product lines Authored Global procedures for EU/UK/China RoHS (Restriction of Hazardous Substances) and EU/UK REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)