Gowthaman Nandagopal Email & Phone Number

India

Ensuring global regulatory compliance for class II medical device (monitoring devices)Practising regulatory assessment for new device and also for design change.Specialized in Software and cybersecurity global regulatory requirement.EU MDR technical file preparation and update

Karnataka, India

Supported Quality and regulatory role for medical Device and cell therapy products.Ensuring the site QMS compliance for ISO13485 and 21CFR820Facilitate the Quality management review meeting site level.Represented as Site Auditee for MDSAP,13485 and 9001 with no major non-conformancesSupported in preparing technical file for the EU MDR/IVDR complianceEnsuring the regulatory compliance for New Product/Design change for class II medical devices

Bengaluru Area, India

Supported Quality and regulatory role for medical Device and cell therapy products.Ensuring the site QMS compliance for ISO13485 and 21CFR820Facilitate the Quality management review meeting site level.Represented as Site Auditee for MDSAP,13485 and 9001 with no major non-conformancesSupported in preparing technical file for the EU MDR/IVDR complianceEnsuring the regulatory compliance for New Product/Design change for class II medical devices

Bengaluru Area, India

Expert in preparing the Class III medical Device Technical Dossier for US FDA 510 K and EU MDR Submission.Instrumental in getting the US FDA 510K, EU MDD,MENA and TGA Australia marketing clearance for the Class III medical Device by Axio BioSolutions Implementation of the EU MDR related deliverables across product Development and related training to the stakeholders.Ensure compliance of product labelling, marketing claims, advertising materials to ensure compliance with federal and different country regulationsManages in getting the Local DCGI India approval/renewal for license to manufacture for sale/distribution of medical devices.Conducting and Leading the Internal Audits and Quality representative for the Externals Audits (ISO 13485 and EU MDD).

Manipal,Karnataka

Preparation and review of the QMS documents related to the manufacturing, testing and release for clinical trial of the allogenic mesenchymal stem cells as per the 21 CFR part 1271 HCT/P’s requirement.Author, edit, review and approve SOP’s, Policies and guidance documents. Manage and administer quality processes within the company’s quality system.Preparation and submission of Technical dossier for medical Device to CDSCO India.Conducted the Supplier Audit and Internal Audit as per ISO 9001 and ISO 13485 QMS Compliance.Handled the Surveillance, recertification audits of ISO 9001:2008 with Scope of Audit “Development and Processing of Stem Cells for Clinical Trials”.

Tamil Nadu, India