Quality & Regulatory Compliance Issues in the Medical Device & Diagnostics Industry

Taryn Kern is quality management professional with extensive experience in the Medical Device / Pharma /Biomedical industry for compliance to ISO 13485, 21 CFR 820, 21 CFR Part 11, 98/97/EC, MDD for CE Mark regulations. She is a certified Principal Medical device (ISO 13485:2016) Auditor and ISO 13485:2016 Lead Auditor. She has extensive experience in building QMS systems, managing changes using a risk-based approach, 3rd party critical supplier management, internal/external audits, hosting audits, compiling technical files, gap assessments, overseeing design control processes & QMS interlinks. In her current capacity at Cellsolutions LLC, as a Quality and Regulatory Affairs Manager, she led the transition and gap analysis of ISO 13485: 2003 to ISO 13485: 2016 for successful re-certification by SGS to ISO 13485:2016. She is also responsible for CE Mark of product for EU market; technical file development, management and continuous improvement; Design control management; validation management. She has vast knowledge and hands on experience in, transitioning legacy paper-based systems into 21 CFR Part 11 compliant systems for document control, complaint handling, CAPA, auditing and response to 483`s. She is also competent in training and mentoring personnel on Quality, Process, Supplier Improvement Engineering as per the company or regulatory or compliance directives.