Find Jobs
Hire Freelancers

Compliance Guide for Medical Devices

$30-250 USD

Closed
Posted 15 days ago

$30-250 USD

Paid on delivery
Our client has provided us with the intended use document for software as a medical device, detailing its purpose and general description. While previous consultations resulted in a classification of this device as a class-1 medical device, we now require a comprehensive document that includes the following 3 elements: CLASSIFICATION - The classification of the device based on various medical device framework directives, a justification for this classification, and a list of applicable standards for this software as a medical device. ESSENTIAL REQUIREMENTS - Additionally, the document should outline the essential evidential requirements to demonstrate that the essential standards have been met. RISK ANALYSIS - Furthermore, it should include a thorough risk analysis, detailing potential risks associated with the software, the severity of their consequences, and their likelihood. The ultimate goal of compiling this information is to ensure that the software conforms to current standards, thereby enabling the client to seek a declaration of conformity. [login to view URL]
Project ID: 38068368

About the project

24 proposals
Remote project
Active 15 days ago

Looking to make some money?

Benefits of bidding on Freelancer

Set your budget and timeframe
Get paid for your work
Outline your proposal
It's free to sign up and bid on jobs
24 freelancers are bidding on average $77 USD for this job
User Avatar
I am damn sure that I can complete this project "Compliance Guide for Medical Devices" beyond your expectations and within your given time and budget. I am a specialized writer who has been providing professional writing services since 2017 and I have 800+ reviews with 4.8 ratings. In this industry, to produce 100% output the most important thing is the “CREATIVITY” because every time clients demand something “Unique, New & Better”. Since 2017, I have found myself highly creative and this is the main reason for my success because I have achieved the 99% client satisfaction ratio. I have mastered multiple writing skills such as; Investor Ready Business Plans, Pitch Deck Presentations, Financial Models, Feasibility Reports, ATS Resume/CV, Job-winning Cover Letters, Optimized LinkedIn Profiles, White Papers, Grants, Press Releases, Biographies, Speeches, Letters, Website Contents, Articles, Blogs, Book/eBooks, Product Descriptions, and Editing and Proofreading. Please click on the "Award" button to hire me. I am waiting for you, "Thank You"
$30 USD in 1 day
4.8 (579 reviews)
7.2
7.2
User Avatar
Hi! As an experienced regulatory consultant with a strong background in medical device regulations and documentation, I am well-equipped to deliver high-quality results that align with your objectives. I have carefully reviewed the intended use document and understand the specific requirements outlined for the classification, essential requirements, and risk analysis of the software. I will conduct a thorough assessment of the device based on relevant medical device framework directives to determine the most appropriate classification. I will provide a well-justified classification along with a comprehensive list of applicable standards for your software as a medical device. I will outline the essential evidential requirements necessary to demonstrate compliance with the essential standards for your software. By clearly documenting how these requirements have been met, we will ensure that your software adheres to current regulatory standards. I will conduct a detailed risk analysis that identifies potential risks associated with the software, evaluates the severity of their consequences, and assesses their likelihood. By meticulously analyzing these factors, we can develop effective risk mitigation strategies to enhance the safety and performance of your software. With my expertise and attention to detail, I am confident in my ability to deliver results that exceed your expectations. Regards, Zohaab
$140 USD in 7 days
4.9 (84 reviews)
6.7
6.7
User Avatar
I have read and understood all your project details "Compliance Guide for Medical Devices" and I feel my self the best candidate to complete this project with 100 percent accuracy. I am Faisal Mahmood, I have more than 10 Years of experience in crafting tailored solutions for success, including; Business Plans, Pitch Decks, Feasibility Reports, Resumes, Cover Letters, and LinkedIn profiles. Over the past ten years, I have consistently delivered exceptional results, helping clients navigate the competitive landscape with precision and finesse. With a proven track record spanning ten years, I bring a wealth of experience to every project, ensuring not just quality but a profound understanding of evolving industry dynamics. My approach is rooted in precision, innovation, and a relentless pursuit of perfection, setting a standard that goes beyond expectations. I am damn sure that you will love my services, try me once at least. I am anxiously waiting for your messages.
$30 USD in 1 day
4.7 (220 reviews)
6.4
6.4
User Avatar
Compliance Guide for Medical Devices My name is Rabia Faisal, I am working in the writing industry since 2011. During this time, I have served countless clients with a full amount of satisfaction by providing them with TOP Quality Solutions. I have command of all references APA, Harvard, IEEE, MLA & Chicago, etc. I will provide plagiarism-free work with 100 percent accurate grammar within your given deadline. Please message me to get Top Class Services. I am waiting; https://www.freelancer.com/u/TopWritingGuru
$30 USD in 1 day
4.8 (133 reviews)
6.1
6.1
User Avatar
I take great pride in writing compelling content for comprehensive Compliance Guide for Medical Devices! Good day! I can create the document for software as a medical device, detailing its purpose and general description. I'm Rabia, a professional and versatile content writer having 9+ years of experience, I possess a proven track record in conveying complex technical information in a clear and concise manner. My writing style is user-friendly, making it accessible to a broad audience. Your content would incorporate the following elements: • Maintenance Instructions • Summary • Documentation & references of a content • Troubleshooting Tips If you're looking for someone who pays attention to detail, cares about the little things, and will work hard to deliver a product you can be excited about, I'm at your service! Reach out to check relevant samples. Best Regards, Rabia.
$30 USD in 1 day
4.9 (36 reviews)
5.3
5.3
User Avatar
Hi, I understand your need for a comprehensive document outlining the classification, essential requirements, and risk analysis for your software as a medical device. Starting with classification, I'll justify its classification as a class-1 device under relevant medical device directives and list applicable standards. Moving on, we'll outline essential evidential requirements, ensuring compliance with essential standards by documenting adherence in design, development, and testing. Concluding with a thorough risk analysis, we'll identify potential risks associated with the software, assess their severity and likelihood, and detail mitigating measures. This document aims to facilitate regulatory compliance, enabling your client to seek a declaration of conformity and ensuring alignment with current medical device standards and regulations. I'm committed to delivering a concise yet comprehensive document that meets your requirements, streamlining the regulatory approval process for your software as a medical device. Let's come on chat Regards, Moiz
$140 USD in 7 days
4.6 (51 reviews)
5.8
5.8
User Avatar
As a seasoned freelancer in medical device compliance, I can create a comprehensive guide for your software, ensuring adherence to regulatory standards. I'll meticulously classify the device, outline essential requirements, and conduct a thorough risk analysis. This will streamline the declaration of conformity process, ensuring compliance and regulatory approval.
$50 USD in 2 days
4.9 (44 reviews)
5.5
5.5
User Avatar
Hello dear, I am a professional writer with over 9 years of experience in the field of writing. I am a professional in providing high quality writing service. I am interested in this project. I have completed many similar projects before. You’ll find my content as 100% unique, grammatically correct, engaging, and of high-quality. I am confident that I will be able to lend my talents to you in this way. I have also a good experience in article writing, research writing, copy writing, blog writing, business plan, marketing plan, case study, Financial analysis, Power point presentations, writing tasks, Essays, Proposals, Rewriting tasks, Technical Reports, financial plan. I can deliver your work according to your requirements. I can deliver high quality work with tight deadline. Hopefully, I get this opportunity to work with you as I am sure it will be a good working experience. Kindly come on chat for detailed discussions. I will complete your job as soon as possible. Thank you.
$30 USD in 1 day
5.0 (63 reviews)
5.2
5.2
User Avatar
Compliance Guide for Medical Devices My name is "Usama Safdar" and I am a Ph.D degree holder which means I am highly-capable to tackle this project "Content Editor " with 100 percent accuracy. I am a professional writer with over 6 years of experience in writing; Essays, Research Summaries, Thesis, Dissertation, Lab Reports and Case Studies. I always provide High-Quality Solutions within the shortest possible time with all instructions followed against very reasonable prices. I can manage works even with shortest deadlines like; "2500 words work in just 6 Hours" with very reasonable time. As a pro academic writer I am also familiar with all the referencing styles; such as APA, Harvard, OSCOLA, IEE, MLA etc. I always provide plagiarism-free solutions and as a prove I also provide "FREE Turnitin reports". For Samples, please visit my profile https://www.freelancer.com/u/SolutionMart Please message me to start the discussion. Thank You
$30 USD in 1 day
4.9 (22 reviews)
4.7
4.7
User Avatar
Hi, I have seen your your project details and I am the "BEST CANDIDATE" for this job "Compliance Guide for Medical Devices". I am Aisha Mujahid, an experienced professional offering comprehensive writing services tailored to elevate your brand and communications. I have a proven track record and a 99% satisfaction ratio from over 2500 clients, and I am eager to contribute to your project's success. I offer comprehensive services tailored to meet your diverse needs. My services are; Article & Blog Writing, Website Content, Book/eBook Writing, Product Descriptions, Presentations, Resume/CVs, Cover Letters, LinkedIn Profiles, Business Plans, Pitch Deck Presentations, Feasibility Reports, YouTube Scripts, White Papers, and Grant Writing. Let's collaborate to craft compelling narratives that leave a lasting impact. I look forward to enhancing your brand through the power of words.
$30 USD in 1 day
4.9 (24 reviews)
4.6
4.6
User Avatar
With a perfect blend of technical writing and digital marketing skills, I am confident that I am the best fit for your project. My expertise lies in crafting engaging and informative pieces that not only convey complex information clearly but also spark high levels of interest – a crucial aspect for compliance guides. I understand the intricacies of compiling medical device documentation and have previously worked on similar projects covering classification, essential requirements, and risk analysis. My approach always involves thorough research and analysis, ensuring that all applicable medical device framework directives are carefully considered, providing solid justifications for the classification chosen. My content writing proficiency extends to include matters of legality and risk analysis, which is fundamental in generating comprehensive and accurate material. I have practical experience within digital marketing with precise use of keywords to ensure the nature of content meets standards. Additionally, my background in branding enables me to present your document in a polished yet easily- digestible manner that aligns with your brand identity. You can trust me to deliver an impressive compliance guide for your medical software device by ensuring it conforms to current standards, demonstrating its adherence to essential requirements, while minimizing potential risks. Let's work together to make sure you get the declaration of conformity you need.
$50 USD in 5 days
5.0 (16 reviews)
4.6
4.6
User Avatar
Hello, With 8 years of experience in technical writing, particularly in the realm of medical products, I assure you of impeccable service. My expertise in compliance documentation ensures a comprehensive guide exceeding your expectations. I've handled similar projects, always meeting deadlines without compromising quality. Beyond writing, I possess a deep understanding of legal and regulatory aspects concerning medical devices. My adeptness in research ensures accurate classification and identification of applicable standards. Risk analysis is a core strength, blending my social science background with technical writing skills to identify and quantify risks effectively. Together, we can navigate your project towards conformity with confidence. Let me leverage my skills to transform your vision into reality! Best regards, Umber
$140 USD in 7 days
5.0 (2 reviews)
4.2
4.2
User Avatar
Hi, As a seasoned expert in medical device regulations and documentation, I am poised to undertake the task of compiling a comprehensive document outlining the classification, essential requirements, and risk analysis for the software as a medical device. Drawing on my expertise, I will meticulously assess the intended use document provided by the client and navigate through various medical device framework directives to determine the appropriate classification for the device. In crafting the document, I will provide a detailed justification for the chosen classification, accompanied by a comprehensive list of applicable standards for the software as a medical device. Furthermore, I will outline the essential evidential requirements necessary to demonstrate compliance with the essential standards, ensuring clarity and transparency in the regulatory process. With a focus on thoroughness and accuracy, I will conduct a comprehensive risk analysis, identifying potential risks associated with the software, assessing their severity and likelihood, and proposing mitigation strategies where necessary. Your satisfaction is my guarantee! Just message me & consider your project is done. Thanks.
$250 USD in 7 days
4.7 (10 reviews)
4.4
4.4
User Avatar
Compliance Guide for Medical Devices I am a professional MBA writer with more than 7 years of experience in every field of writing. I did thousands of projects with 100% accuracy and on requirements, My promises included; best efforts, plagiarism-free work, deadline guaranteed, your privacy protection! I did many assignments, quiz, business plan, sales, and marketing plan, SEO articles & blogs, many more, etc. please come to the chatbox and try me once I am confident I will not let you down. waiting for your reply thank you. Please see samples of my recent work via the link: https://www.freelancer.com/u/Stopsolution
$30 USD in 1 day
4.9 (33 reviews)
4.2
4.2
User Avatar
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
$39 USD in 1 day
5.0 (10 reviews)
3.5
3.5
User Avatar
Understanding the significance of compliance in the medical device industry, I, Param Nandkishor, bring forth my invaluable experience in technical writing to cater to your project's core requirements. Having worked in similar capacities for over four years, I believe my skills are perfectly tailored to execute this task efficiently. My exceptional knowledge of medical device frameworks enables me to precisely classify devices based on the applicable directives while providing a detailed rationale behind each classification. These classifications will be further reinforced through a comprehensive list of relevant standards. In crafting the essential requirements of the software, I have a keen eye for detail and can gather and analyze evidential data to demonstrate thorough compliance with essential standards. Consequently, your software will be equipped with a robust risk analysis encompassing all potential hazards, severity levels, and their likelihoods. Beyond just abiding by the strictness of clinical compliance measures, my goal is also to ensure optimum safety for your end-users. Overall, I am confident in my ability to provide you with a well-structured document that not only meets regulatory standards but also amplifies patient safety. Let me help you navigate the complex terrain of medical device compliance as we work together towards your declaration of conformity.
$60 USD in 1 day
4.8 (5 reviews)
3.2
3.2
User Avatar
Grettings! I am existing after reading your project details about "Compliance Guide for Medical Devices " I have completed MPhil in business administration and I have about 4 year experience in all type of business subject, science subjects, technical subjects and engineering too. I have also a good experience in business plan, marketing plan, case study, financial plan, feasibility study, article, blogs etc. I will provide you plagiarism free work with unlimited revision plus free turnitin report. Thanks for reading, I am waiting for your response please go through the link and check my samples: https://www.freelancer.com/u/QuickMentor
$30 USD in 1 day
4.8 (11 reviews)
2.9
2.9
User Avatar
"Hey Newham, I have carefully reviewed the project requirements for the Compliance Guide for Medical Devices. To meet the objectives outlined, I propose to begin by conducting a detailed analysis of the software as a medical device. This will involve thorough research on various medical device framework directives to accurately classify the device. I will then compile a comprehensive document that justifies the classification, lists applicable standards, and outlines the essential evidential requirements needed for conformity. Furthermore, I will conduct a rigorous risk analysis to identify potential risks associated with the software, assess the severity of consequences, and determine their likelihood. By providing a detailed risk analysis, the client will have a clear understanding of the safety implications of the software. I am prepared to dedicate the necessary time and expertise to deliver a high-quality Compliance Guide that meets all the specified requirements. Best regards"
$30 USD in 1 day
5.0 (4 reviews)
2.6
2.6
User Avatar
Hi there Newham S.! I have read your instructions keenly, and this is something I can comfortably do. I have advanced experience in Compliance, Medical Products, Medical Devices Sales and Technical Writing. I am excited to use my skills to help achieve your project goals. Please feel free to reach out if you need additional details on how I can complete this task. Thank you Bredah
$160 USD in 1 day
0.0 (0 reviews)
0.0
0.0
User Avatar
"Hi, I hope you are doing well today. I am very excited to work in this project. I have eight years of experience in writing. I have thoroughly read your requirements. I have informed you about the tasks that I offer to the free or paid service clients. They are as follows- • Article writing, article rewriting, copy writing, copy typing • Content writing, research writing, book writing, editing, technical writing, ghostwriting. • PDF, creative writing, business writing, proofreading, translation, report writing, blog writing. • SEO writing, academic writing, story writing, proposal writing. • Content strategy, academic research, medical writing, publishing, Grant writing, academic medicine. • Fiction, screenwriting, copy editing, essay writing, report writing, editorial writing, speech writing, romance writing, online writing. • Short stories, web page writer, technical documentation, newsletters, academic publishing. • Test strategy writing, travel writing, test plan writing, data entry work (word, power point and excel) Thanks Best Regards.
$30 USD in 1 day
0.0 (0 reviews)
0.0
0.0

About the client

Flag of UNITED KINGDOM
London, United Kingdom
4.9
36
Payment method verified
Member since Sep 9, 2017

Client Verification

Thanks! We’ve emailed you a link to claim your free credit.
Something went wrong while sending your email. Please try again.
Registered Users Total Jobs Posted
Freelancer ® is a registered Trademark of Freelancer Technology Pty Limited (ACN 142 189 759)
Copyright © 2024 Freelancer Technology Pty Limited (ACN 142 189 759)
Loading preview
Permission granted for Geolocation.
Your login session has expired and you have been logged out. Please log in again.