Infomed Consulting

Infomed Consulting specialises in bridging Asia-Pacific medical device companies to global opportunities. Whether you're an Australian startup seeking FDA clearance, a New Zealand company targeting EU MDR compliance, or a Southeast Asian manufacturer exploring African markets, we're your regulatory pathway experts: EU MDR compliance and GMP guidance African market entry through SAHPRA registration TGA-to-global regulatory pathway optimisation ISO 13485 and quality management systems Market entry strategy and distribution planning FDA, EU approvals for Australian & New Zealand companies : Australia → FDA, EU, Africa expansion, Global market strategies New Zealand → Global market access, EU, Africa access, In-Country Sponsor South Africa → Global market access, EU, FDA, SAHPRA management APAC → African market entry, Global expansion : Serving both traditional (FDA/EU) and emerging (African) markets : 95% first-submission approval rate across all jurisdictions : Remote consultation option benefits clients located anywhere in the world : Strategic African market entry while pursuing premium markets : From concept to post-market surveillance 🤝 '- Australian/NZ medtech seeking FDA or EU market entry - Southeast Asian company exploring African opportunities - An APAC medical device manufacturer needing regulatory guidance - Looking for cost-effective market entry strategies - Wanting to diversify beyond traditional markets