プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Hafsa I.に依頼

Pakistan

Medical Device & SaMD Consultant | MDR | CER & BER | ISO 13485 | Technical & Design Files | Risk Management | Production

プロフィール概要

Medical Device Production & Regulatory Consultant with 7+ years of experience in device development, technology transfer, and regulatory compliance for both medical devices and Software as a Medical Device (SaMD). Skilled in preparing and reviewing Technical Files, Design Files, Biological Evaluation Reports (ISO 10993), Clinical Evaluation Reports (MDR), Risk Assessments (ISO 14971), and SOPs. Experienced in ISO 13485 QMS implementation, audit readiness, and regulatory submissions across EU MDR, FDA, SFDA, and other markets. Strong background in procurement, shelf-life studies, manufacturing licensing, and SaMD compliance (including clinical evaluation, risk management, and PMS/PMCF documentation). Recognized for attention to detail, clear communication, and efficient project management supporting organizations in achieving regulatory approvals, certifications, and successful market entry.

専門分野

• ★ Medical Device Manufacturing
• ★ European Medical Device Regulation (MDR)
• ★ ISO 13485
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Interventional Cardiology
• ☆ Regulatory Affairs
• ☆ Medical Equipment & Supplies
• ☆ Product Evaluation
• ☆ Material Sourcing
• ☆ Reverse Engineering
• ☆ Supply Chain & Logistics
• ☆ Inventory Control
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Packaging Design
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ SOP & Protocol Writing
• ☆ White Papers

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, General Proofreading & Editing

Research Market Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Scientific and Technical Research

Consulting Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping, Reverse Engineering, Device Fabrication

職務経験

Deputy General Manager (Operations)

N-ovative Health Technologies

7月 2023 - 現在

学歴

PhD Biomedical Sciences

National University of Sciences and Technology

9月 2017 - 9月 2023

MS Biomedical Sciences

National University of Sciences and Technology

9月 2014 - 1月 2017

認定資格

• ISO 13485 Medical Device Quality Management Systems Lead Auditor Training Course Certificate xxxxxxxxx / 199690711 CQI / IRCA 686997

  SGS United Kingdom Ltd

  http://learning.sgs.com/cerificateverify/

  10月 2025 - 現在

• ISO 13485

  SGS UK

  1月 2021 - 現在

出版物

JOURNAL ARTICLE

Hafsa Inam, Murtaza Najabat Ali, Ibraheem Raza Jameel, Dil Awaiz, Zunaira Qureshi (2024). Development of Robust PEBAX-Based Angiographic Catheter: Design and In Vitro Study . Materials.

Mukhtiar, N., Ali, M.N., Inam, H.(2021). Design and development of impurities free pyrolytic coated mechanical bi-leaflet heart valve prototype . Pakistan Heart Journal. 54. (3). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 277-284.

CONFERENCE PAPER

Inam, H., Najabat Ali, M., Javed, F.(2022). Design Development and Modeling of the Laser-Cut Reinforced Shaft for Radiopaque Media Delivery to Coronary Artery Using Finite Element Method . ACM International Conference Proceeding Series. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 101-107.

Saifullah, F., Inam, H., Ali, M.N., Ansari, U.(2019). Magnetically targeted drug delivery system through imaging technology PID feedback control, and MATLAB . ACM International Conference Proceeding Series. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 142-148.

BOOK CHAPTER

Majid, M., Shafqat, S., Inam, H., Hashmi, U., Kazi, A.G.(2014). Production of algal biomass . Biomass and Bioenergy: Processing and Properties. 9783319076416. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 207-224.