Andrew Goodenough
Head of Quality and Regulatory Prolight Diagnostics @Prolight Diagnostics
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WORK HISTORY
Head of Quality and Regulatory Prolight Diagnostics @Prolight Diagnostics
EDUCATION
The Open University
180 Points, Engineering
Quality and Regulatory Formal Training
Medical Devices
ABOUT ANDREW GOODENOUGH
Medical device quality management systems for design and manufacturing (ISO 13485/FDA 21CFR Part 820/ISO9001).• Medical device risk management to (ISO 14971) and associated standards, including software to IEC 62304.• Medical device / IVD compliance, development and CE marking process.• Medical device regulation 2017/745 EU, and IVD regulation 2017/746 EU.• Medical Device pFMEA and process validation (IQ/OQ/PQ).• Internal / external auditing to ISO 9001, ISO 13485 and FDA 21 CFR Part 820.• Medical device/IVD/laboratory equipment concept through to regulatory approval.• NRTL accreditation process (CSA/UL/ETL/TUV/MET).• Waste framework directive.• CFDA (NMPA) Chinese medical device submissions.• MDSAP preparation and audit support.• Supply chain management.• Microsoft Office Excel/VBA/Word and SharePoint (highly proficient).• Laboratory management and safety (ISO 17025).• Laser safety (EN60825).
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