Mr. Sinto Poulose is a highly experienced professional with over 17 years of expertise in the manufacturing and testing of medical devices and in vitro diagnostic (IVD) products. With a strong foundation in biochemistry, Sinto is an approved chemist and a lead consultant for CE Marking under the EU IVDR 2017/746, trained by the British Standards Institute (BSI). His extensive knowledge in this domain makes him a key figure in regulatory compliance and quality assurance.
Sinto is an IRCA-CQI Certified Lead Auditor for ISO 13485:2016 and ISO 9001:2015 Quality Management Systems, also trained by BSI. Additionally, he holds the certification as an InternalAuditor for ISO 15189:2012, having been trained by the Bureau ofIndian Standards (BIS). His deep understanding ofinternational standards has been critical in ensuring that organizations meet rigorous quality and regulatory requirements.
Beyond auditing, Sinto has substantial experience in clean room facility design and construction, along with navigating complex regulatory submissions, including those for USFDA, CDSCO, and CE compliance. His comprehensive expertise spans all facets of regulatory processes, ensuring that medical devices and IVD products meet the highest global standards.
Mrs. Selma S is an accomplished professional with over 19 years of experience in the manufacturing and testing of medical devices and in IN VITRO DIAGNOSTIC (IVD) products. Holding a postgraduate degree in Molecular Biology & Biotechnology, she is an approved chemist and a recognized leader in her field. Her expertise includes serving as a Lead Implementer for the EU MDR 2017/745, ensuring that medical devices meet stringent European regulatory standards.
Selma is an IRCA-CQI Certified Lead Auditor for ISO 13485:2016 and an InternalAuditor for SA 8000 Quality Management Systems, trained by the British Standards Institute (BSI). Additionally, she is an approved InternalAuditor for ISO 15189:2012, certified by the Bureau ofIndian Standards (BIS). Her strong foundation in quality management and regulatory compliance has been instrumental in upholding high standards across various organizations
Beyond her auditing and compliance roles, Selma is actively involved in startup facilitation, where she lends her expertise to design and technology vetting, technical documentation, and regulatory submissions. She also leads client training initiatives, helping organizations navigate complex regulatory landscapes and achieve success in their compliance efforts.
Dr. Chandranand is an accomplished professional with a multifaceted career spanning regulatory testing of biologics, in-vitro diagnostics, research, accreditation, certification, active engagements in industry-academia collaborations, and the medical devices industry. Renowned for his impactful contributions to the medical devices and in-vitro diagnostics sectors.
Served for 25 years as Scientist & Deputy Quality Manager and Researcher at National Institute of Biologicals (NIB), Ministry of Health and Family Welfare, Government of India.
Served as program coordinator for WHO-Prequalification and WHO collaborating Centre at National Institute of Biologicals.
Served as CEO, BioValley Incubation Council (DBT-BIRAC-BioNest Incubator) @ AMTZ: Led strategic initiatives to foster innovations, preparedness towards WHO-PQ for in-house manufacturers of in-vitro diagnostics, conceptualized key projects viz; ICMR kit validation laboratory and Biobank at AMTZ.
Regulatory and WHO-PQ consultant – TATA medical diagnostics limited.
WHO-PQ Consultant – WHO prequalification for in-vitro diagnostics @ Centre for Cellular and Molecular Platforms and Bill and Melinda Gates Foundation
Mentor and Policy Advisor: Actively engaged in mentoring startups, PhD scholars and post graduates in medical devices and in-vitro diagnostics thesis works and dissertations.