Umair A.

Medical Devices Expert / ISO 13485 / ISO 14971 / FDA / MDR / SaMD | EU MDR, FDA, SFDA, CE & Technical Files | PRRC I am a Senior Regulatory Affairs Consultant with 8+ years of hands-on experience in global medical device compliance. I specialize in guiding high-risk devices, Class III implantables, IVDs, SaMD, and combination products through EU, FDA, SFDA, UKCA, TGA, and DRAP regulatory pathways, ensuring audit-ready documentation, compliance, and timely market approvals. I provide end-to-end regulatory solutions, including device classification, technical documentation, regulatory submissions, post-market surveillance, risk management, and PRRC services. My goal is to help companies navigate complex regulations efficiently while maintaining the highest standards of safety and performance. 🌐 Global Regulatory Expertise: 🔹 EU MDR 2017/745 – CE marking, Technical Documentation, EUDAMED registration, UDI compliance, PRRC services (Article 15) 🔹 US FDA – 510(k) submissions, Quality System Regulations (21 CFR Part 820), post-market compliance 🔹 SFDA (Saudi Arabia) – Class C device submissions, PMS reporting, local regulatory compliance 🔹 UKCA / MHRA – Device registration, compliance audits 🔹 TGA (Australia) – Regulatory approvals, documentation compliance 🔹 DRAP (Pakistan) – Device registration, submissions 📌 Core Regulatory Deliverables: - Clinical Evaluation Reports (CERs) – MDR Annex XIV & MEDDEV 2.7/1 Rev.4 - Biological Evaluation Reports (BERs) – ISO 10993 series - Risk Management Files – ISO 14971:2019 - Technical Documentation – DHF, DMR, DHR, CE marking dossiers, FDA submissions - Verification & Validation Reports - Post-Market Surveillance (PMS) & PMCF Reports - Declaration of Conformity & GSPR Checklist - Labelling & Instructions for Use (IFU) 💼 Regulatory Project Experience: - Balloon stents & catheters – CER, BER, Technical File - Hypodermic needles – FDA & CE submissions - Wound management devices – PMS and technical documentation - Breast cancer detection software (SaMD) – Clinical evaluation & global regulatory strategy - IVD blood collection & DNA/RNA extraction kits – CE marking & regulatory submissions 🏆 Regulatory Experience Highlights: - Acting as PRRC, ensuring EU MDR & EUDAMED compliance for clients - Preparing, reviewing, and maintaining technical files, CERs, BERs, Risk Management Files, DHF/DMR/DHR, PMS reports - Managing global regulatory submissions across EU, FDA, SFDA, UKCA, TGA, and DRAP - Advising on device classification, intended use, borderline cases, and combination devices - Implementing and auditing Quality Management Systems in compliance with ISO 13485:2016 - Ensuring risk management and product lifecycle compliance per ISO 14971:2019 My expertise includes: • ISO 13485 Quality Management System implementation • Quality Manual preparation and documentation control • SOP (Standard Operating Procedure) development • Work Instruction creation • Form and template development • CAPA (Corrective and Preventive Action) systems • Nonconformity and deviation management • Risk Management documentation (ISO 14971) • Gap Analysis for ISO 13485 and EU MDR compliance • Internal audit preparation and audit support • Technical Documentation / Technical File preparation • Device Master Record (DMR) and Device History Record (DHR) • Change Control and Document Control systems • Supplier qualification and vendor management • Complaint handling and Post Market Surveillance (PMS) • Clinical Evaluation documentation support • Validation protocols and reports Validation Expertise: • IQ (Installation Qualification) • OQ (Operational Qualification) • PQ (Performance Qualification) • Process Validation • Equipment Validation • Cleaning Validation • Packaging Validation 🧩 Regulatory Standards & Compliance Knowledge: - ISO 13485:2016 – QMS implementation & audit readiness - ISO 14971:2019 – Risk management for medical devices - ISO 10993-1 – Biocompatibility evaluation - ISO 62366 – Usability engineering - ISO 15223-1 / ISO 20417 – Labelling & device information - IEC 60601-1 / IEC 62304 / IEC 82304-1 – Electrical & software safety - FDA 21 CFR Parts 11 & 820 – Quality system and electronic records Why Hire Me for Regulatory Affairs: ✅ Global Expertise: End-to-end RA support across EU, FDA, SFDA, UKCA, TGA, and DRAP ✅ High-Risk Device Specialist: Class III implantables, combination devices, IVDs, SaMD, borderline cases ✅ Comprehensive Documentation: CERs, BERs, Technical Files, DHF/DMR/DHR, PMS, labelling, IFU ✅ PRRC Services: Acting as your dedicated MDR compliance officer ✅ Audit-Ready & Compliant: Standards-driven, meticulous, reliable, and timely ✅ Strategic Guidance: Regulatory strategy, classification, submissions, lifecycle compliance Let’s Connect: Message me to discuss your device regulatory needs. I provide expert guidance to achieve fully compliant, market-ready, and audit-proof documentation worldwide.