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USD 50 /hr

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☆☆☆☆☆

Hire Dr. Hafsa I.

Pakistan

USD 50 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

Deputy General Manager (Operations)

N-ovative Health Technologies

July 2023 - Present

Education

PhD Biomedical Sciences

National University of Sciences and Technology

September 2017 - September 2023

MS Biomedical Sciences

National University of Sciences and Technology

September 2014 - January 2017

Certifications

• ISO 13485

  SGS UK

  January 2021 - Present

Publications

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). p. 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. p. 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. p. 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. p. 207-224.