60 plus years of combined experience in a highly regulated Life Sciences industry - Medical Devices, Diagnostics and Biologics:

Alex Chang

CEO, Co-Founder

Anupam Talapatra

Co-Founder and Partner

John Vuong

Co-Founder and Partner

• Demonstrated track record of International Regulatory Compliance – product authorizations, clearances, and approvals in different geographies (US / Canada / European Union (EU) / APAC /Australia)
  • Extensive submission experiences in the US and EU – includes Pre-Sub (Q-Sub), 510(k), de novo and PMA for US FDA ; Design Dossier and Technical Files for EU
• Excels at strategizing and implementing action plans to address Regulatory hurdles (e.g., IVDR) and Quality challenges, in support of new product introduction and maintenance of on-market products.
• Possesses the communication skills needed to cultivate positive relationships with FDA, Notified Bodies, EU Competent Authorities, Authorized Representatives and global Regulatory agencies.
• In-depth understanding of technical and regulatory aspects of:
  • Lab Diagnostic products involving molecular technologies / bead-based immunoassays / homogeneous enzyme immunoassays / clinical chemistry assays.
  • Point-of-Care devices.
  • SaMD / non-invasive sensor-based Digital Health products.
• Experience with biomarker assays in oncology, infectious & inflammatory diseases, metabolic disorders, and cardiovascular diseases; blood screening assays; Therapeutic Drug Monitoring (TDM) assays, Urine Drug Tests.
• IVD Program Management => led cross-functional QMS, Design Control and product lifecycle initiatives involving R&D, QA / QC, Manufacturing, Validation, Clinical Operations, Medical Affairs, Product Management, and Executive Leadership.
• Implemented e-QMS modules and trained teams to use e-QMS based systems.
• Built and commissioned GMP facilities and QC laboratories for IVD & Biologics manufacturing by working closely with internal stakeholders and external vendors
• Developed, implemented, and managed processes and procedures to enable Manufacturing area QA / QC and Clinical Laboratory (CLIA) Quality
• In-depth knowledge of:
  • Regulation (EU) 2017/746 (IVDR) | Regulation (EU) 2017/745 (MDR) | SOR/98-282 (Health Canada) |Therapeutic Goods (Medical Devices) Regulations 2002 (TGA Australia) | Medical Device Rules 2017 (CDSCO, India).
  • US FDA Regulations: 21 CFR Parts 801, 803, 807, 809, 812, 814, 821, 822, 830, 860, 862, 864, 866, 870, 210, 211, 600.
  • US FDA 21 CFR Part 11.
  • ISO 13485:2016 | 21 CFR Part 820 | MDSAP Audit Approach 2022.
  • ISO 14971:2019 | ISO/TR 24971 (Medical Device Risk Assessment).
  • IEC 62304 (Medical Device Software & SaMD lifecycle processes) | IEC 62366 (Usability)
  • Regulatory Guidance documents from FDA, MDIC, IMDRF & MDCG | MEDDEV guidance documents (developed by working groups on behalf of European Commission) | ARGMD (Australian Regulatory Guidelines for Medical Devices) | ICH Guidelines
  • CLSI Standards for Diagnostics | ISO Standards for Medical Devices (related to Performance, Safety, Stability, Labeling, Risk Management)
  • ISO 15189 | CAP, CLIA & NYSDOH requirements for Clinical Lab | 42 CFR Part 493 (Laboratory Requirements)