---
title: "Muhammed Shahal V - Clinical Process Specialist I in Perintalmanna | Tal"
description: "Meet Muhammed Shahal V, Post-Market Surveillance Specialist | PSUR | PMSR | Complaint Handling | PMCF | IFU & Labeling | SSCP | EU MDR 2017/745. based in Perintalmanna."
image: "https://tal.club/meet/muhammed-shahal/share-image"
---

# Muhammed Shahal V on Tal

## Headline

Post\-Market Surveillance Specialist \| PSUR \| PMSR \| Complaint Handling \| PMCF \| IFU & Labeling \| SSCP \| EU MDR 2017/745\.

## Location

Perintalmanna

## Work experience

Clinical Process Specialist I at Dr\.Klinisch Research Pvt Ltd, Apr 2025 \- Present · 1 yr 4 mos, Bangalore, Preparation and review of Post\-Market Surveillance Plans \(PMSP\), PMS Review Reports \(PMSR\), Periodic Safety Update Reports \(PSUR\), PMCF Plans, and PMCF Evaluation Reports in accordance with EU MDR 2017/745\. Preparation and maintenance of Instructions for Use \(IFU\), Labeling documentation, and Summary of Safety and Clinical Performance \(SSCP\) to support regulatory compliance\. Review and analysis of post\-market surveillance data, literature, vigilance information, and PMCF outcomes to evaluate the safety and performance of medical devices\. Coordination with Regulatory Affairs, Clinical, Quality, and Risk Management teams to ensure consistency across PMS, CER, SSCP, and Risk Management documentation\. Support for vigilance activities, trend evaluation, CAPA monitoring, and implementation of documentation updates based on PMS findings and regulatory changes\. Contribution to clinical investigation activities including Source Data Verification \(SDV\), CRF review, data reconciliation, and documentation management in accordance with GCP principles\. Development and maintenance of regulatory documentation templates, trackers, and data analysis tools to improve process efficiency and compliance\. Compliance with applicable EU MDR requirements, MDCG guidance documents, ISO 13485, ISO/TR 20416, and related medical device regulations\.

Safety Surveillance Analyst at Dr\.Klinisch Research Pvt Ltd, Apr 2024 \- May 2025 · 1 yr 2 mos, Bengaluru, Karnataka, India, Overall responsibility of Monitoring and Managing site activities\. Data Management, and Documentation of Clinical trials Overall response for Post Market Surveillance activities as per ISO TR 20416 and Annex III of EUMDR Key role in designing Periodic Safety Update Report as per MDCG 2022\-21 Guidelines and EUMDR Responsible for preparing clinical documents such as Post Market Clinical Follow Up as per EUMDR Annex XIV Part B and Usability Engineering Report as per IEC 62366 Key role in designing Instruction for Use\. Medical Device Label Reviewing as per ISO 15223\-1:2021 Summary of safety and clinical performance\. CAPA Management

Clinical Research Associate at Dr\.Klinisch Research Pvt Ltd, Aug 2022 \- Aug 2024 · 2 yrs 1 mo, Bengaluru, Karnataka, India, Overall response for Post Market Surveillance activities as per ISO TR 20416 and Annex III of EUMDR Key role in designing Periodic Safety Update Report as per MDCG 2022\-21 Guidelines Responsible for preparing clinical documents such as Post Market Clinical Follow Up as per EUMDR Annex XIV Part B and Usability Engineering Report as per IEC 62366 Clinical Investigation as per ISO 14155 Key role in designing Instruction For Use and Labeling Provide training to newly joined trainees in basics of EUMDD and EUMDR

Campus Ambassador at Internship Studio, Dec 2020 \- Jul 2021 · 8 mos, India

Biomedical Engineer trainee at Moulana Hospital Perinthalmanna, Apr 2021 \- Apr 2021 · 1 mo, Malappuram, Kerala, India, A 5 days internship under biomedical engineering department at Moulana Hospital

## Education

Bachelor of Technology \- BTech, Biomedical/Medical Engineering, APJ Abdul Kalam Technological University

[View the original profile](https://tal.club/meet/muhammed-shahal)

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