Medical Devices CONSULTANT & Preparation of technical documentation as per NEW EU Regulations 2017/745 for Medical Devices

I am an experienced and a professional research writer with a strong background in technical documentation writing. I am well aware of similar tech documentation standards and significance. I would really like to discuss this project further. I am known for my quality and plagiarism free work. Please visit my profile to explore my previous client's reviews on similar projects.

Hi there, I have read your project description and i'm confident i can do this project for you perfectly.I still have a few questions. please leave a message on my chat so we can discuss the budget and deadline of the project. Thanks . .

Hi there, I have read your project description and i'm confident i can do this project for you perfectly.I still have a few questions. please leave a message on my chat so we can discuss the budget and deadline of the project. Thanks . .

Hi. Since functioning from 2008, I have accomplished hawk eye for the requirements, and I have all the aptitudes to produce showpiece as per your anticipations. Creating a masterpiece is an art, and I am a master in it. For further discussions, please message me in private messenger so we may finalize the deal. Looking Forward; Top Writing Guru

Hi, I am good in your required project, I also have a huge amount of working experience of more than 7 years. To ensure please visit my profile and check customers satisfaction level. https://www.freelancer.com/u/toplinesolutions To begin, please send me a message. I will complete your project within your given deadline. Thank you.

PMP, MBA and project manager. I have worked on govt. contracts, SRS documents and currently I helped a Xray baggage company with preparing and filing of all documents for govt. approval. I also have keen interest in medical devices, biotech field and medicine in general So certainly I can help with this. I will need the following: 1. Examples of similar final product if any 2. Sufficient and timely inputs from your team. 3. We might need to hire a graphic designed ( if needed). This bid is placeholder. I am not sure of the volume of work yet.

Hello there I am glad to find your good project today. We have good experience in this field and we can do your work in best possible way. As an expert, our skills and work results will exceed your expectations. I am very dedicative to the details and I am a friendly person and always open for the suggestions and discussions. Feel free to contact us. Kindly text me so that we can further discuss this work. Thanks

Hi, I can assist you with preparing of technical documentation as per NEW EU Regulations 2017/745 for Medical Devices. I have my masters in Medicine from Dow University Karachi. Please message me for the detailed discussion. Thanks, Sidra

Dear Sir/Madam, I would like to apply for your ISO Certification project. I have an MBA degree with courses in ISO 9001 (Quality Management System), ISO 14001 (Environmental Management), OHSAS 18001 (Occupational Health & Safety), ISO 22301 (Business Continuity) and ISO 27001 (Information Security). I have been working as Regulatory Affairs Officer with Medical Device Company American Screenings LLC for the last one year and have registered their products with Health Canada and now working on Mexico. I also manage ISO 13485 QMS and have prepared Tech File for the company last month and now next project is MDSAP. I have provided Consultancy and developed documentation for the following projects: 1- ISO 9001 at Aversion Technologies Inc., USA. 2- ISO 9001 at WaterStore Poly Tanks, Australia. 3- ISO 9001 and ISO 14001 Integrated Management System at Calair Pipe Systems, Australia. 4- Quality Plan and OH&S Plan at SBS Construction, Australia. 5- ISO 22716 Cosmetic GMP at PurOlea Cosmetics Lab, USA. 6- ISO 22000 Food Safety at Sim & Ros, Cambodia. 7- HACCP Plan for Food Safety at Station Grill, New Zealand. 8- USDA National Organic Program at Bagestan, USA. 9- ISO Lead Auditor Training Management System at NTSS, Turkey for IRCA, UK. 10- ISO 17025 Laboratory Management System I am really excited by your project and would like to discuss it at a time of your convenience. Waiting for a positive response from your side. Yours Sincerely, Kamran Vardag

Hello there. I organized, completed and maintained a CE Compliance Technical Document for my previous company for 3 years. I am very familiar with how European Compliance Technical Documents work and can help you with this quickly and professionally.

I have read your project details. I have to ask a few questions. Can you please message me via chat so we can discuss all the details to elicit all the requirements and hence start the development? I will showcase all the skills and my experience for this project over the chat. Please message me so we can resume this discussion. Can you provide me all the functional/Non-functional requirements via a document?

Hello! I specialize in creating academic and scientific content. My clients hire me to write, proofread or edit scientific texts and manuscripts. I love my job and will gladly help you with your project.

16 years experience with Philips Cerner and Siemens healthcare. Expert in Software as medical devices. Please indicate your email and will send a detailed profile.

Hi, I am an experienced medical device professional currently in the field and working on EU-MDR transition process. I have close to 10 years of experience in the industry and hands on working experience in Quality and Regulatory requirements of MDD and Technical file preparation of various medical devices including reusable surgical devices. I can contribute my free-time for this project. Please let me know if you wish to discuss further. Thanks Indu

Hello, I am currently writing Technical Documentation for MDT Neurosurgery and have completed 3 files till now. I have completed thorough gap assessment of current QMS documentations for the product in comparison with General Safety & Performance Requirements. I have worked on class I, Ir & IIa device so far. I have worked on technical documentation of the active devices and radioactive devices as well. I have written PMCF plan, charted PSUR. I have completed 12 design history files and thorough understanding of 21 CFR 820 & MDR. While working for last 11 years in medical device industry I have worked in almost all aspects of process to bring the product to market. This brought me a thorough understanding of ISO 13485, inter relation of processes and enhancing processes performance. This experience is helping me to effectively write technical documentations. In the above tasks, it is important that details of each deliverable are provided. A structured approach and template building can be done by me but details like ISO 10993-1 testing, CMR substances test, manufacturing process flow charts, approved intended use, usability analysis, verification & validation test details, proof of compliance with harmonized standards etc. are expected to be ready to meet proposed 28 days completion time. I can share list of details required and per that data can be exchanged. Sincerely Shrikant