Sundeep Agarwal

As part of the leadership team, he advises on regulatory strategy for global partnerships, risk assessment, and mitigation planning across multiple markets. He has led global regulatory approvals (CE, FDA, CDSCO, Health Canada) and product registrations across India, EU, US, UK, and APAC, while serving as Head of Quality Assurance & Regulatory Affairs, Management Representative, and PRRC (EU). His expertise spans QMS leadership, software validation (SDLC), cybersecurity, and product lifecycle management, ensuring compliance from R&D through clinical evaluation and post-market surveillance. At Remidio Innovative Solutions, he plays a key role in enabling globally compliant, scalable healthcare innovations.

Leadership Team, Advice on global compliance, Regulatory Strategy for global partnership, Risk Assessment and Mitigation planning, Head of Quality Assurance and Regulatory Affairs, Lead Global Regulatory Approvals (CE & FDA, India, Health Canada), Indian Licensing, Software Validation - SDLC, Cybersecurity, Lead QMS, Product Life Cycle Management, Management Rep., PRRC for EU, Official Correspondent - FDA, Product Registration and Approval for India, EU, US, UK, APAC, Support R&D, Clinical Evaluation and Post Market Surveillance at www.remidio.com

Head of Quality Assurance & Regulatory Affairs. Management Representative for Quality Management System (EU, US, TGA, CDSCO). Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the European MDR. Official US FDA correspondent for Datt Mediproducts. Authorized Representative under the Medical Device Rules 2017 CDSCO India. Communicate and interact with several Ministry of Health (CA/NB). Product Registration and Approval for India, Europe, United States, United Kingdom, Germany, South Korea, Malaysia, Indonesia, Sri Lanka. Bangladesh, Ghana and South Africa. Review & Author - CE Technical dossiers as per (EU MDR) 2017/745, Design File for Class I, II and III products (including animal origin, Drug+Device Combinations), Clinical Evaluation Report as per MEDDEV 2.7, Rev 4 Facilitate & Lead new product development from Research to commercialization Risk-Based Process Development and Documentation Developed and Author - Device Master File, DHF, DMR Plant Master File, General Safety & Performance Requirements, Risk Analysis & management File, Usability Engineering, FMEA, EMC, Software Validation, Validation & Verification (IQ, OQ, PQ) Handling of third party audits (Notified Bodies), Customer inspection, Suppliers audits, CAPA, Customer complaints, Internal Audits, Quality Manual & SOP Post Market Surveillance & Post Market Clinical Follow-up

Key Responsibilities: Quality Control, Quality Assurance, Clean room validation, Biocompatibility, Packaging validation, Risk Analysis, Software Validation, Software development life cycle, Third Party Audits, Vendor Audits, CAPA, Internal Audits,Certification, GMP, GLP, GCP, Clinical Trials, Regulatory Submissions, Product Registration.

Position Description: Auditing & Technical document Reviewer for FSC, PEFC, Chain of Custody Programs, Business Strategy for environmental audits, VOC, Head for UAE Certification business.

Position Description: Responsible for certification, technical documentation - DSIR & IIHR audits, Support & Coordination with R&D for new developments. Business empanelment with APEDA, NAFED & other Government Institutes, Technical support to the financial proposal for projects funding with NAFED, Liasoning with Government Bodies

Leadership and Business Excellence

https://medschool.duke.edu/about-us

Executive Education on Advance Quality Management

Medical Law and Ethics