New member: Copia QA
Copia QA is a medical device consultancy formed by David Broderick who has over 20 years experience of medical devices in both the quality and regulatory fields.
Experience has been gained in areas including 510(k) submissions, Technical File compilation, risk management, supplier controls – including extensive experience in supplier auditing, CAPA, ISO 13485 implementation, IEC60601 – medical electrical devices, FDA remediation work, internal auditing, validation, design controls etc. He has also carried out several value creation projects which have resulted in significant cost savings.
David has an initial Honours Degree in Metallurgy and Materials Science, he also has an MBA from the Open University.