25+ years across Asian MedTech — commercial excellence, regulatory affairs, and market entry strategies for multinationals and startups.
Credas is a Singapore-based medical device consulting firm — accelerating MedTech innovation with deep industry expertise in regulatory affairs, quality systems, medical affairs, and market access.
Founded with vision, built on trust. Credas delivers world-class regulatory and clinical expertise to MedTech startups and multinationals entering or scaling in global markets. With a global outlook and strong regional presence, we transform regulatory challenges into opportunities — driving growth through deep industry knowledge and clinical expertise.
A board-certified surgeon on our team translates clinical reality into regulatory strategy — bridging the gap between innovation and approval.
From concept and pre-clinical studies to multi-jurisdiction registration, market access, and post-market surveillance — one integrated partner.
Deep specialisation in software medical devices, IVDs, AI/ML medical devices, and digital therapeutics — IEC 62304, ISO 42001, EU AI Act ready.
Comprehensive support spanning quality, regulatory, clinical, market access, communications, and capability building.
QMS implementation aligned with ISO 13485, MDSAP, EU MDR, US FDA QMSR, ISO 27001/27701/42001, and SS 620 GDPMDS.
Learn moreStrategic regulatory pathways and submissions across the US FDA, CE, Health Canada, UK CA, HSA, TGA, CDSCO, SAHPRA, and more.
Learn morePre-clinical strategy, clinical evaluation, CER/CEP, PMCF planning, and clinical investigation design under MDR & ISO 14155.
Learn moreHTA, market opportunity assessment, and Singapore company registration — your APAC regional headquarters, simplified.
Learn morePeer-reviewed publications, clinical narratives, and scientific illustrations — translating complex science into clarity.
Learn moreCapability building for QMS, regulatory frameworks, and SaMD/digital health — by certified lead auditors and surgeon-trainers.
Learn moreUnited for MedTech success.
A multidisciplinary team uniting hands-on clinical expertise with deep regulatory, quality, and commercial leadership across Asia, Europe, and beyond.
25+ years across Asian MedTech — commercial excellence, regulatory affairs, and market entry strategies for multinationals and startups.
Germany-based Q&R consultant — 12+ years in MedTech, IVD, and SaMD compliance. Former Director at Veranex.
Board-certified urology surgeon and notified body veteran — EU MDR, CER/CEP, and clinical investigation expertise.
A strong regional presence supported by trusted partners across Asia Pacific and Europe — enabling seamless cross-border collaboration on every engagement.
Singapore — the strategic gateway to Asia Pacific MedTech.
Germany — European Authorised Representative (EAR) and PRRC.
CDSCO submissions, India Authorized Agent (IAA), and commercial launch in India.
TGA Sponsor and commercial launch in Australia.
Japan PMDA, Thailand FDA, Malaysia MDA, Philippines FDA, Brazil ANVISA, Kenya PPB, GCC.
Whether you’re a startup seeking your first registration or a multinational expanding into new markets — our team is ready to partner with you.