Write ISO 13485 QMS

We are looking to build a ISO 13485 QMS for our condom business. The scope of the business is that we are working as a service supplier to a condom company. We receive condoms in bulk packs which we ... Read More

I'm a PhD student in Engineering with a Master's in Statistics. Expert in Matlab, Minitab Econometric and statistical modeling of pretty much everything you can think of. These include expertise on protocol development, research study designs, sample size calculations, data management, and data analysis using various statistical software’s (i.e. STATA, Eviews, R & SPSS), statistical interpretation and report writing. Currently involved in official approval of internal econometric models that banks are using.

Hello Sir/ Madam I would like to apply as a writer in your job post. I believe that you are looking for a professional and expert writer who is talented, concise and oriented to detail when developing the content of the ISO 13485 QMS. I am the most suitable candidate for the position. My six years’ experience as an academic writer and a technical writer, writer have helped me develop mastery in creating unique content that is well-researched and precisely crafted to inspire and add value to the targeted audience. If awarded the project, I will prove to be a valuable asset in I will bring forth all my skills that are needed for developing a comprehensive ISO 13485 QMS that provides a clear and concise framework for the operations of your company. I will also detail critical evidence proving how your company understands the Quality Management System through process consistency as well as the accomplishment of your set goals and objectives. I will work on providing a detailed educative and informative document that professionally highlights the QMS policies, procedures, and plans that your company has undertaken to meet the ISO 13485 requirements. I will also develop all the necessary documentation required to prove how your company has the capacities and is equipped to meets the ISO Standard requirements. I am open to further deliberations concerning the project. Please do not hesitate to contact me. Regards Sam

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

I have about four years of experience as a QA Manager for a US manufacturer of medical devices and more than eleven years of experience in industry and Quality Assurance. I would need to know the timeframe for this project. Please review my profile and let me know if you need further information.

Standards covered ISO 13485 2016 Ata ispec 2200 Dita Scorm Aicc Mstp Oracle Chicago I'll provide you with standards based quality management systems documentation as per ISO to help you complete the regulatory requirements Adobe certified technical writer and digital marketer to deliver a wide range of tech, academic and research writing in different styles. I provide a complete solution that fits your specific project more than just the exact requirement. I am professional technical writer with 10 years of experience in software, web, and IT industry. Writing is just one thing, I will offer you much more than that to make this project – your best ever! Here’s a list of my USPs • Core technical writing in different formats, styles, compliance and on high-end IT technologies • SEO-winning content powered by advanced paid SEO tools ahref and SEMrush • Content and influencer marketing expertise • Native language expertise with fast turnaround at best price • Academic writing with multi-format citation, referencing, and stylesheet • Original, Copyscape cleared content

Dear Sir/Madam, I would like to apply for your ISO 13485 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 am working as ISO 13485 Regulatory Affairs Officer for the last six months at American Screenings LLC which is selling Medical Testing Devices in different countries. I have got templates of procedures of ISO 13485. 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. 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... Greetings... I am a Pharma Quality Regulatory expert from India. I have more than 6 years of experience. I have worked with many Pharma and Medical Device companies like CIPLA, Torrent Pharma strides shasun, and amenal pharmaceutical as a Regulatory QA manager. I understand your requirement and I can help you to execute this project. looking forward to work on this project. I am available for Skyp interview. regards Anam

I run a company which is developing an In Vitro Diagnostic Device which has to be fully compliant with 13485 and also fulfill 21 CFR part 11 of the FDA. I used to work in the life sciences space for large cos like pharmacia corporation, Pfizer and Pharmacia & Upjohn in the united states and I have implemented QMS systems for them including an award winning e-submission solution to the FDA. There are approx 107 SOP's which need to be in place for 13485 and I can help develop them for you. Key aspects of the process will be having a quality manual in place and working through the V & V process.