Regulatory strategy, TGA product registration, FDA compliance, 510k/PMA submissions, MDD & IVDD technical files/design dossiers, medical device reporting (MDR), post market surveillance
ANZ sponsorship for international companies, market assessment, product launch strategies & evaluations, selection & ongoing management of distributors, competitor analysis, tender submissions
Clinical strategy & trial management, protocol development, clinical marketing, post-market feedback & data analysis, identifying key opinion leaders (KOLs), preparation of abstracts & manuscripts
Quality Management Systems (QMS) consulting & training, ISO9001/13485 & QSR/GMP gap analysis, SOP & policy development, internal & supplier audits
