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.

Martin Schnorpfeil

Martin Schnorpfeil is a highly accomplished medical technology professional with over 30 years of international experience in engineering, auditing, and executive leadership. His career spans hands-on technical roles, senior management positions, and extensive regulatory expertise across Europe, North America, and Asia.

At TÜV SÜD Product Service GmbH (EU-Notified Body for Medical Devices), Martin served as Lead-Auditor/Auditor for more than five years, conducting over 100 audits worldwide. His portfolio includes surveillance, certification, recertification, unannounced audits (UAA), and complex multi-site MDSAP audits — covering standards such as ISO 13485, MDD, AIMD, MDR, and MDSAP. He has worked extensively with software as a medical device (SaMD), software in a medical device (SiMD), implantable devices, IVDs, and imaging systems.

Martin’s leadership journey includes serving as Chief Technical Officer and Director QM&RA, overseeing R&D, quality management, and international regulatory affairs. He has also held appointments as Person Responsible for Regulatory Compliance (PRRC) and Management Representative (MR) in global markets. Throughout his career, Martin has demonstrated a commitment to innovation, patient safety, and advancing healthcare technology worldwide.

David Pudwill

David is a former US FDA Lead Medical Device Reviewer and Branch Chief with nine years of regulatory experience at the agency. During his tenure, he contributed to DARPA (Defense Advanced Research Projects Agency) projects advancing defense-driven medical technologies and consulted with both CBER (Center for Biologics Evaluation and Research) and CDER (Center for Drug Evaluation and Research) on complex regulatory submissions — particularly for combination products. He was also a founding member of the Kidney Health Initiative, underscoring his commitment to advancing public health innovation.

In addition to his government service, David has held senior leadership roles in medical device companies, including serving as Head of Regulatory Affairs in a fractional capacity for multiple organisations. His past corporate experience includes positions such as Senior Vice President and Head of Regulatory Affairs at AscentX Medical and Senior Director of Regulatory Affairs at ConvaTec USA. He also supports startups in securing funding and navigating FDA and Department of Defense interactions, building on a career foundation that began at St. Jude Medical.

This blend of regulatory expertise, industry leadership, and government experience enables David to bridge the gap between regulatory bodies, corporate strategy, and innovative startups. His unique perspective helps organisations advance medical devices and combination products in highly regulated environments.