Surgeon. Specialist. Strategist.

Muthukumar Krishnan

A seasoned healthcare leader with over 25 years across Asia — including Singapore, Southeast Asia, and India — specialising in commercial excellence, regulatory affairs, and market entry strategies. He has led high-impact initiatives for Johnson & Johnson MedTech, commercial teams, and agile startups, including co-founding a venture to establish commercial and regulatory operations.

He is credited with registering and launching innovative medical devices and Software as a Medical Device (SaMD) solutions during the formative years of SaMD adoption, while setting up commercial operations across the region and advancing healthcare delivery. Recognised with multiple leadership awards, he brings a people-driven, technology-enabled approach to improving healthcare outcomes.

Somashekara Koushik Ayalasomayajula

Koushik is a seasoned Quality & Regulatory Affairs consultant based in Germany, with over 12 years of experience in medical devices, IVD, and digital health (SaMD).

He previously served as Director of Quality & Regulatory Affairs at Veranex, leading global compliance initiatives and supporting innovation across health technologies. He has also supported the World Health Organization (WHO) as an Inspector for IVD prequalification activities.

Koushik specialises in regulatory strategy, global submissions, and Quality Management Systems implementation (ISO 13485, ISO 27001, MDSAP, US FDA QMSR, EU MDR/IVDR). With over a decade of experience, he has led MDR QMS transition programmes and guided M&A-driven QMS integrations.

He is also a trainer in regulatory compliance, auditing, and digital health (AI/ML, software lifecycle management), with expertise in implementing cybersecurity best practices and information security controls to safeguard sensitive health data.

His track record includes successful US FDA clearances, EU CE marks, WHO collaborations, and approvals across Health Canada, UK CA, CDSCO India, ASEAN countries, South Africa, South Korea, GCC, and China. Recognised for his ability to balance compliance with innovation, Koushik brings a people-driven, technology-enabled approach to advancing healthcare worldwide.

Professional Certifications

• ASQ-CMDA — Certified Medical Device Auditor, American Society for Quality
• RAC-Devices — Regulatory Affairs Certification (Devices), RAPS
• CQI IRCA Certified Lead Auditor — ISO 13485:2016 Medical devices QMS
• CQI IRCA Certified Lead Auditor — ISO/IEC 27001:2022 Information security management systems
• Trained Internal Auditor — MDSAP / MDD / MDR

Dr. Abinaya Adithya

Dr. Abinaya Adithya, board-certified urology and oncology surgeon since 2011, is a seasoned Medical Affairs Director with global expertise in clinical practice and regulatory leadership. She currently leads medical affairs at Credas, drawing on extensive experience across Europe, the UK, and Asia.

At qtec Services GmbH, Germany, she directed EU MDR clinical and regulatory strategies, authoring key documentation such as CERs, CEPs, IFUs, PSURs, SSCPs, and clinical investigation files. Her background with notified bodies provides deep insight into quality management, risk management, and post-market surveillance. She previously served as a clinical reviewer at TÜV SÜD Product Service GmbH, Germany, evaluating documentation for diverse devices including implantables, and led clinical affairs for SaMD across Europe and the USA.

Dr. Adithya began her career as a urological surgeon at University Hospital Leipzig and holds a German medical license. She has also worked within healthcare systems in the UK, Hungary, and India, and completed advanced training in ISO 13485 and ISO 14971. As a trainer at Credas, she delivers programmes for medical device manufacturers, pharmaceutical companies, competent authorities, and notified bodies — focusing on clinical evaluation, literature searches, and clinical investigations.