Creating a Risk Assessment Document (according DIN EN ISO 14971:2018/MEDDEV 2.7.1) for a simple Medical Device (personal lubricant).

Hi we are a team of PhD and MD in biotechnology, biomedical engineering and medical fields. I have 7 years of research and writing experience and have worked on PhD level thesis projects, published papers in peer reviewed journals and have also worked with several companies on creating research based reports, books, blogs, essays, white papers, patents, SEO articles, product descriptions and formulating novel products. I have excellent academic writing skills and statistical analysis skills in R , spss, excel to complete any assignment in high quality. Looking forward to discussion, Best Regards, Suyash

I am supposed to write risk assessment document. I have worked on many papers in report writing, research.I have read and understood your requirement and I know you will never regret, thank you.

Dear Sir/Madam, I would like to apply for your ISO 9001 and MSDS project. I have an MBA degree with courses in ISO 9001, ISO 14001 (Environmental Management), OHSAS 18001 (Occupational Health & Safety), ISO 27001 (Information Security) and ISO 22301 (Business Continuity). I have done Risk Assessment and Mitigation as it is now a mandatory part of ISO 9001:2015. I have a Risk Register Excel Sheet that calculates the Risk Priority Number (RPN) by multiplying the Probability/Likelihood of Occurrence with the Consequence. The Probability and Consequence are further based on four or five factors which have weights and the excel sheet calculates the RPN based on the inputs. 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 Vadag

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Hi How are you? I can help you with your project. I have many years experience in the medical device field in roles such as; quality systems, regulatory affairs and risk management. I have as required a certificate in risk management for medical devices which covers ISO14971 (2007 for ROW and 2012 for EU - 2018 revision not released yet) and MEDDEV 2.7.1 (Ver 4). I am also a certified lead auditor in ISO13485:2016 and knowledgeable on requirements of MDR2017/745. (I can complete this project for 700EUR if you would like to contact me through my website) Please don't hesitate to contact me if you would like to chat about this project. Thanks Stephanie

I DO NOT OUTSOURCE I have been a freelancer for the past 8 years, I believe that my experience and skill in this background will prove to be of great help to you. Contact me to discuss more on the details

Respected Client I would like to propose on this Project. Since the scope of this particular project is falls under my expertise. I have an overall 5 years experience in both Medical Device and Pharmaceutical Engineer as a Quality and Compliance engineer. Where I lead Risk Management Summary team, CAPA, NCR and Validation studies. To achieve the milestone and the target. I would prefer to get a Scope, Timeline, Cost, and Deliverables with its respective requirements (including any validation studies / CQA, etc). Looking forward to hearing back from you soon. Yours Sincerely Shanthoshee M S

Hello , PhD pharmacist here , I have some knowledge in quality procedures and assessment ( university certification ) . I look forward to help you . Edouard