Credas Pte. Ltd. is a Singapore-based medical device consulting firm — founded by industry veterans and supported by a board-certified surgeon, to bridge the gap between clinical reality and global regulatory excellence.
Credas was founded in Singapore by alumni of Johnson & Johnson MedTech, led by MedTech consultants and a surgeon-entrepreneur who recognised a critical gap: pairing world-class regulatory and quality expertise with deep clinical insight, delivered with the agility of a boutique partner.
Our team brings decades of leadership across the world’s most demanding healthcare systems — guiding both multinationals and startups through complex regulatory pathways across Asia, Europe, and the Americas.
Today, Credas partners with manufacturers ranging from early-stage MedTech startups to established global players. Our work spans Class I to Class III medical devices, in vitro diagnostics, SaMD, AI-powered diagnostics, and combination products.
What sets us apart is our integrated team — a board-certified surgeon working alongside lead auditors, regulatory strategists, and commercial leaders — ensuring every regulatory decision is grounded in clinical reality and every clinical insight becomes a compliant, market-ready strategy.
Three principles shape every engagement at Credas — guiding how we work with clients, regulators, and partners across the globe.
Seamless collaboration across continents — Singapore, Germany, India, and Australia — bringing the right expertise to every challenge, every time.
Quality and compliance are not regulatory checkboxes — they are the foundation of trust between manufacturers, regulators, and the patients they serve.
Recognised credentials, audited processes, and a track record of approvals across the world’s most demanding regulatory authorities.
A global outlook with strong regional presence — uniting deep industry knowledge with clinical expertise across diverse markets.
Singapore — the strategic gateway to Asia Pacific MedTech.
Germany — European Authorised Representative (EAR) and Person Responsible for Regulatory Compliance (PRRC) Services for non-EU manufacturers.
CDSCO submissions, India Authorized Agent (IAA), and commercial launch in the world’s fastest-growing MedTech market.
TGA Sponsor Services and commercial launch in Australia.
Japan (PMDA), Thailand (Thai FDA), Malaysia (MDA), Philippines (FDA), Brazil (ANVISA), Kenya (PPB), and the GCC.
From Class I to Class III devices — including implantables, capital equipment, surgical instruments, and combination products.
In vitro diagnostics including software-driven IVDs, with WHO Prequalification expertise and notified body experience.
Software as a Medical Device, including AI/ML-powered solutions — IEC 62304, ISO 42001, and EU AI Act readiness.
Whether you’re a startup seeking your first registration or a multinational expanding into new markets — our team is ready to partner with you.
