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I’m part-way through registering a Class I medical device with the Therapeutic Goods Administration and need a documentation specialist to get the application package over the line. Most of the groundwork is done, but several sections still need polishing, cross-referencing, and compilation into the exact format the TGA portal expects. You will pick up my partially completed material, identify gaps, and produce a submission-ready bundle that meets ISO 13485 and TGA Essential Principles. In practical terms, I’m expecting the final hand-off to include, at minimum: • a fully indexed technical file, • risk management documentation brought into line with ISO 14971, • a concise clinical evaluation summary (literature-based is fine for Class I), • labelling/IFU alignment with the Essential Principles, and • the Declaration of Conformity prepared for electronic lodgement. Please factor in one feedback round; after that I’d like a clean, editable Word/PDF set ready for upload. If you’ve shepherded Class I products through the Australian process before and are comfortable with the TBS portal workflow, we should be able to wrap this up quickly.
Project ID: 39742767
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8 freelancers are bidding on average $400 AUD for this job

Hi, As an accomplished academic and technical writer with a diverse range of skills, I believe I am the ideal candidate to bring your medical device registration project to completion. My professional background, which includes a PhD in Computer Science and an MBA, reflects not only my understanding of the required technicalities but also the astuteness necessary for navigating the intricate documentation process. Having published extensively in reputed international journals, including those in the medical and scientific fields, I am well-versed in producing submission-ready documents that meet the highest quality standards. My proficiency extends to aligning risk management documentation with ISO 14971, conducting comprehensive clinical evaluations, creating precise labelling, and ensuring conformity with essential principles - all skills specifically outlined in your project. Additionally, I understand that time is of the essence for you. That's why my proven track-record of efficient project delivery will be immensely beneficial. Having shepherded various medical devices through Australian regulatory processes, I am intimately familiar with the TGA Essential Principles as well as TBS portal workflows. Rest assured, my end product will include a fully indexed technical file along with a clean, editable Word/PDF set ready for upload while maintaining meticulous adherence to ISO 13485 and TGA regulations. Let's wrap this up expertly and efficiently together! Thanks
$500 AUD in 7 days
7.8
7.8

"TGA Class I Docs Prep " I feel you are Looking for engaging, high-quality Work that drives results! With 6+ years of experience, I specialize in SEO blogs, business & marketing plans, content writing, presentations, resumes & cover letters, feasibility studies, books & eBooks, technical writing, and many more. I’ve helped 4,000+ clients with impactful, reader-friendly, and plagiarism-free content tailored to their needs. Why Choose Me? ✅ SEO-Optimized & Engaging Writing ✅ 100% Original, Error-Free, & Well-Researched ✅ Persuasive Business & Marketing Plans ✅ Timely Delivery & Open Communication Check my portfolio & achievements: https://www.freelancer.com/u/QualityHub Let’s discuss your project—I’m just a message away!
$250 AUD in 1 day
6.7
6.7

Affordable, Early Delivery. ★★★★★★★★★★★★★★I hold a Masters degree which gives me the requisite background to handle writing from various subjects. I am a highly committed person towards my work. You can rely on QualityXenter for quality and consistency in writing. We never violate copyright rules. I have vast amount of experience in this industry since I am working from 2015 as a professional writer. I provide many modifications till to get your satisfactions. I have access to enough journals to use in your research project. I always produce quality work at VERY LOW RATES so, don't worry if you have a low budget for your work, I will be very happy to make a new client like you. I am producing quality work for my clients including ARTICLE WRITING, REPORT WRITING, ESSAY WRITING, RESEARCH PAPERS, BUSINESS PLAN, TECHNICAL WRITING, MATLAB, THESIS, ACCOUNTING & FINANCE work ETC. Go through my profile link https://www.freelancer.com/u/qualityxenter
$250 AUD in 1 day
6.1
6.1

This sounds like something I can absolutely deliver ? Clean, professional, user-friendly, and seamless is how I build — no fluff, just results. From smart design to integrated automation, I create systems that look great and work even better. While I’m new to Freelancer, I’ve completed plenty of successful projects off-site with happy clients and real outcomes. I’d love to chat more about your project! Regards, Jarrod.
$400 AUD in 14 days
0.0
0.0

As an accomplished professional in the corporate industry with a particular focus on report and research writing, I am confident that I can swiftly and skillfully complete the task of preparing your TGA Class I documents. My vast experience in crafting submission-ready bundles that are fully compliant with ISO 13485 and TGA Essential Principles coupled with my familiarity with ISO 14971 for risk management creates an unparalleled advantage to accelerate this process for you. Moreover, drawing from my prior successful journeys shepherding other Class I products through the Australian regulatory process, I have acquired an intimate understanding of the TBS portal workflow facilitating efficiency in every step. My well-honed indexing and aligning abilities guarantee a comprehensive technical file and fully compliant labelling/IFU unison. Lastly, I recognize and appreciate the value of effective communication and client feedback. Beyond just providing a final hand-off, I guarantee one feedback round to ensure complete satisfaction before delivering a clean, editable Word/PDF for efficient uploading. Let me assure you Rashmi, by selecting me for this project, we will cross that finish line promptly without compromising on quality or compliance!
$500 AUD in 7 days
0.0
0.0

As a highly experienced and reliable documentation expert, my focus has been on delivering content that not only meets industry standards but also dovetails perfectly with specific regulatory requirements. With my extensive background in AI and ML technologies, I bring innovative approaches to traditional processes enabling the most efficient and effective outcomes possible. I am confident that my abilities would be an excellent fit for your Class I medical device registration with TGA. My team's expertise spans not just report writing, research writing, and risk management- which are precisely the skills required for this project- but more broadly, we maintain a constant attention to detail that allows us to identify gaps in documentation and correct them speedily while keeping an eye on cross-referencing and formatting. With our rich skill set and dedication to delivering results in line with ISO 13485 and TGA Essential Principles, I guarantee you a high-quality submission-ready package. Let's wrap this up quickly!
$500 AUD in 7 days
0.0
0.0

I'm an expert in technical writing, documentations, editing, word processing, research writing...all my specialities matches with your requirements. I'm strongly committed towards my work and I can give my 100% in this project
$500 AUD in 7 days
0.0
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