UNVEILING IMPACTFUL METHODS TO STRENGTHEN DEVICE CLAIMS

Presenter:

Smridula Hariharan
Deputy Manager – Regulatory services
CELEGENCE

• 9 Years of medical writing experience including medical devices and Invitro diagnostics. Experience spanning different therapeutic areas and all the different risk class of devices.

• Authored and reviewed several Scientific Validity reports (SVR), Clinical performance reports (CPR), Analytical performance reports (APR), Performance evaluation plans (PEP) and Performance evaluation reports (PERs) for invitro diagnostics in compliance with IVDR.

• Authored and reviewed several Clinical evaluation plans (CEPs), Clinical evaluation Reports (CER), PMS plans and reports, Periodic safety update reports (PSUR), Summary of Safety and Clinical performance (SSCP), Post market clinical performance plans and reports (PMCF), both MDD and MDR compliant.

• Developed SOPs for PMS activities/ documents and templates for CEPs, CERs, SVRs, CPRs, PEP, PERs, PMS and PMCF plans and Reports in compliance with MDR and IVDR requirements.

• Consults on responses and CAPAs to be implemented for NB queries and Major and minor non-conformities raised for CERs and PERs.

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