Hire the best Amazon FBA Assistants in Wazirabad, PK

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  • $25 hourly
    I am a QMS and Regulatory Affairs Expert with over 20 years of professional experience in the medical devices industry. Some of my other specialties include technical writing, including Quality Manual (QM), Standard Operating Procedures (SOPs), Quality Plans, Quality Forms, and other QMS document writing and review for medical device companies and any other business complying with ISO standards such as ISO 9001, ISO 13485, ISO 14001, and SA 8000, among others. I have extensive experience in developing technical files and other necessary documentation in compliance with MDR 2017/745 and MDD 93/42/EEC. Additionally, I can assist you well with the following: • Registration of Economic Operators and Products with EUDAMED • Clinical Evaluation Report • Post Market Surveillance Reports • Risk Management in compliance with ISO 14971 (FMEA, FMECA, etc.) • Incident Response Plan and Report • Audit Preparations/Compliances (USFDA, MHRA, ISO 9001, ISO 13485, ISO 14001, SA 8000) Finally, I am an expert in quality management systems (QMS) for medical devices. I have helped numerous companies implement QMS processes that are compliant with ISO 13485, FDA QSR, and other relevant regulations. I am well-versed in the design, implementation, and maintenance of QMS processes, and can help companies ensure that their QMS is robust and effective. If you are looking for a regulatory affairs consultant, medical device content writer, or QMS expert, I would be delighted to help. Please get in touch to discuss your needs and how I can assist you in achieving your goals. Prepare technical file documentation and quality system documents of medical devices Class I, Class IIa, and Class IIb for compliance with EU MDR 2017/745. Create QMS to ISO 13485:2016 processes and procedures. I have prepared technical documentation for regulatory submission globally Following Documents will be Provided under MDR and FDA in my service plan Declaration of Conformity Design & Manufacturing Information General Safety & Performance Requirements Harmonized Standard Compliance Risk Management Plan Risk Management Report Verification & Validation Report Post Market Surveillance Packaging & Labelling CER Plan. Undertaking. Technical File Summary CER (Clinical Evaluation) BER (Biological Evaluation) IFU EUDAMED REGISTRATION PROCESS As part of the EUDAMED registration process, you will also need to register the details of the person who is acting as the PRRC (Annex VI, Part A 1.4), including their name and address. REGISTER WITH FDA I would also be happy to assist you in developing the dossier and its submission with FDA, USA, in compliance with 510(K), as well as registering your company and device listing with the FDA. This includes: • Submitting the Establishment Registration. • Preparing and submitting the Device Listing. • Updating any changes to the Establishment Registration (e.g., address, change in ownership, etc.) • Notifying the FDA of changes in telephone, fax, or email address to keep lines of communication open. HEALTH CANADA (CMDR) MEDICAL DEVICE REGISTRATION AND APPROVAL In Canada, you must obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or a Medical Device License (MDL) for your Class II, III, or IV device. If you want to distribute licensed medical devices in Canada, you will require an MDEL. Your MDL or MDEL application must be in full compliance with the CMDR and be submitted to Health Canada in conjunction with the appropriate documentation required for your device class. I would also be happy to assist you in submission with Health Canada, in compliance with CMDR, as well as registering your company and device listing with Health Canada. This includes: • Review & analyze the client’s device information • Apply & interpret Health Canada classification rules, applicable to the client devices • Recommend a preliminary device classification to Health Canada • Respond to Health Canada questions • Facilitate a formal classification ruling for medical devices directly from Health Canada • Report back to the client • Address any client questions
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    Virtual Assistance
    Medical Device User Manual
    Good Manufacturing Practice
    Literature Review
    ISO 9001
    Risk Management
    Internal Auditing
    Regulatory Compliance
    Medical Device
    Quality Management System
    Procedure Development
    Technical Documentation
  • $7 hourly
    Hi Guys! I am a Certified Amazon Expert from E Rozgaar I have a Huge Experience in Product Research, Amazon online Arbitrage and Amazon Wholesale FBA. I have helped many colleagues and sellers in Amazon FBA to grow their business. I have all the premium tools for effective product hunting to provide my customers with the best results. I am doing this Work From Last 2 Years. So I am very Proficient in My Work. I Always Look Forward to do the best that My Clients Expects to me. My First Priority is The Satisfaction of My Client
    vsuc_fltilesrefresh_TrophyIcon Amazon FBA
    Ecommerce Website
    eBay Marketing
    eBay Listing
    Amazon Dropshipping
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