— MedTech Expertise. Surgeon Insight

Your vision.
Our expertise.

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.

40+
Years of global MedTech leadership
10+
Regulatory jurisdictions
ISO 13485
MDSAP · Quality management
EU MDR · FDA · HSA
Multi-jurisdiction expertise
WHO PQP
Diagnostic device support
SaMD · AI
Digital health specialists
— Why Credas

A trusted partner for complex MedTech journeys.

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.

01 · Strategic

Surgeon-led perspective

A board-certified surgeon on our team translates clinical reality into regulatory strategy — bridging the gap between innovation and approval.

02 · Global

End-to-end coverage

From concept and pre-clinical studies to multi-jurisdiction registration, market access, and post-market surveillance — one integrated partner.

03 · Specialised

SaMD, IVD & AI expertise

Deep specialisation in software medical devices, IVDs, AI/ML medical devices, and digital therapeutics — IEC 62304, ISO 42001, EU AI Act ready.

— Services

Six pillars across the device lifecycle.

Comprehensive support spanning quality, regulatory, clinical, market access, communications, and capability building.

Core · 01

Quality & Compliance

QMS implementation aligned with ISO 13485, MDSAP, EU MDR, US FDA QMSR, ISO 27001/27701/42001, and SS 620 GDPMDS.

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Core · 02

Regulatory Affairs

Strategic regulatory pathways and submissions across the US FDA, CE, Health Canada, UK CA, HSA, TGA, CDSCO, SAHPRA, and more.

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Core · 03

Medical Affairs

Pre-clinical strategy, clinical evaluation, CER/CEP, PMCF planning, and clinical investigation design under MDR & ISO 14155.

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Value-Added · 04

Market Access

HTA, market opportunity assessment, and Singapore company registration — your APAC regional headquarters, simplified.

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Value-Added · 05

Medical Communication

Peer-reviewed publications, clinical narratives, and scientific illustrations — translating complex science into clarity.

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Value-Added · 06

Training

Capability building for QMS, regulatory frameworks, and SaMD/digital health — by certified lead auditors and surgeon-trainers.

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— Our Team

Surgeon. Specialist. Strategist.

United for MedTech success.

A multidisciplinary team uniting hands-on clinical expertise with deep regulatory, quality, and commercial leadership across Asia, Europe, and beyond.

Muthukumar Krishnan
B.E., M.B.A.
Founder & Managing Director

25+ years across Asian MedTech — commercial excellence, regulatory affairs, and market entry strategies for multinationals and startups.

Somashekara Koushik
B.E., M.Sc., ASQ-CMDA, RAC
Partner & Head — Quality & Regulatory Compliance

Germany-based Q&R consultant — 12+ years in MedTech, IVD, and SaMD compliance. Former Director at Veranex.

Dr. Abinaya Adithya
MBBS, MS
Medical Affairs Director

Board-certified urology surgeon and notified body veteran — EU MDR, CER/CEP, and clinical investigation expertise.

— Global Footprint

Singapore-anchored. Globally connected.

A strong regional presence supported by trusted partners across Asia Pacific and Europe — enabling seamless cross-border collaboration on every engagement.

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Headquarters

Credas Pte Ltd

Singapore — the strategic gateway to Asia Pacific MedTech.

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Strategic Partner

MeinDoc GmbH

Germany — European Authorised Representative (EAR) and PRRC.

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Strategic Partner

Meindoc India Pvt Ltd

CDSCO submissions, India Authorized Agent (IAA), and commercial launch in India.

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Strategic Partner

Resper Solutions Pty Ltd

TGA Sponsor and commercial launch in Australia.

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Partner Network

Asia Pacific & Beyond

Japan PMDA, Thailand FDA, Malaysia MDA, Philippines FDA, Brazil ANVISA, Kenya PPB, GCC.

Let’s navigate your regulatory journey together.

Whether you’re a startup seeking your first registration or a multinational expanding into new markets — our team is ready to partner with you.

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Headquarters
190 Clemenceau Ave, #06-08
Singapore 239924
+65 8082 5838
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