Barkat Ullah K.Private profile: Upwork shows its earnings only to signed-in members, so we check it every few weeks, not daily. MRR here is a rough estimate (Upwork's six-month earnings ÷ months active). Last read Nov 5, 2026.

FDA 510(k) and medical device regulatory consultant for medical device and SaMD (Software as a Medical Device) companies. On Upwork I have prepared and submitted four Class II 510(k)s (one SaMD), logged 1,400+ hours of FDA and medical device regulatory work, and prepared the full package for a Class III device that BfArM in Germany approved for a compassionate-use case. Most of those hours came from about two and a half years with one regulatory CRO (October 2023 to March 2026), followed by an FDA submission scoping project. My work is under NDA, so I do not name clients or devices, but I can talk you through the type of work on a call. FDA 510(k), De Novo and Pre-Submission - 510(k) preparation in eSTAR: device description, predicate comparison and substantial equivalence, labeling, testing summaries - Predicate device search, device classification and regulatory pathway strategy - Pre-Submission (Q-Sub) packages - Sections of a De Novo request for a Class III cardiovascular implant - Responses to an FDA Additional Information request - 510(k) gap analysis before submission SaMD and medical device software - SaMD 510(k) submissions with IEC 62304 software documentation Risk management, biocompatibility and design controls - ISO 14971 risk management plans, hazard analyses and risk management files - ISO 10993-1 biological evaluation plans, reports and test protocols - Design controls: Design History File (DHF), Device Master Record (DMR), traceability matrix Quality management system (QA/RA) - ISO 13485:2016 and FDA QMSR (21 CFR Part 820) gap analysis, SOPs, internal audits, CAPA - Complaint handling, Medical Device Reporting (MDR), FDA inspection readiness - 21 CFR Part 11, labeling and promotional material review EU MDR and CE marking - EU MDR 2017/745 technical documentation and Clinical Evaluation Reports (CER) - The full application package for the BfArM compassionate-use case above Clinical evidence and medical writing - Systematic literature reviews and meta-analyses (PRISMA) using PubMed, Scopus and Web of Science - Biostatistics in R - Protocols, validation reports, technical reports and regulatory medical writing Environmental health and health software review Since June 2025 I have also worked about 15 hours a week as an environmental health researcher for a US nonprofit research institute, studying how environmental exposure affects health. I also review health research and health software from an environmental health angle. The exposure-dose reasoning in that work is the same reasoning ISO 10993-17 toxicological risk assessment uses, which helps when a biological evaluation depends on chemistry data. Working with me I am in Pakistan (UTC+5). My working hours overlap the UK business day and US East Coast mornings. I sign NDAs before I see device files. I have 15 to 20 more hours a week available. To start, send me your device type, its intended use and your target submission date.