Achieve ISO 13485 Certification

$5000-10000 USD

Kapalı

İlan edilme: 3 ay önce

$5000-10000 USD

Teslimde ödenir

I need an experienced ISO 13485 specialist to guide my medical-device company all the way to successful certification, with an emphasis on full compliance with United States FDA requirements (21 CFR 820). Here’s what I expect from our collaboration: • Conduct a gap analysis against ISO 13485:2016 and applicable FDA Quality System Regulation clauses. • Create or refine the entire Quality Management System: quality manual, procedures, records, risk management files, and design-control documentation. • Train my team so daily practices align with the new QMS. • Lead internal audits, support CAPA closure, and prepare us for the registrar’s stage-1 and stage-2 audits. • Be on call during the certification audit until the certificate is issued. Acceptance criteria – All mandatory ISO 13485 documentation is approved and implemented. – Internal audit reports show no unresolved major non-conformities. – Registrar issues an ISO 13485:2016 certificate with no major findings linked to FDA compliance. Please outline your approach, relevant project experience, and estimated timeline when you reply.

Proje No: 40067348

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11 teklifler

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@LiveExperts

Hello, As a seasoned engineer specializing in medical writing and risk management, I bring the unique combination of technical knowledge and compliance expertise that your ISO 13485 project requires. At Live Experts, our mission is to help clients like you navigate through complex regulations and attain peak operational efficiency. My strategy for achieving ISO 13485 certification starts with conducting a thorough gap analysis against the standard's requirements and FDA's Quality System Regulation clauses to identify areas needing improvement. By leveraging my skills in research writing and data analysis, I'll create or refine your entire Quality Management System, aligning procedures with both ISO 13485:2016 and 21 CFR 820 guidelines. Given the extensive scope of your project, timely execution is paramount. Drawing upon my deep-rooted experience in leading internal audits, supporting CAPA closure, and preparing for registrar's audits, I'm confident in delivering results within the estimated timeline. A successful collaboration with me would ensure that all mandatory documentation is implemented, there are no unresolved major non-conformities post internal audits, and you receive an ISO 13485:2016 certificate without any major findings linked to FDA compliance. Choose me for this significant venture. Let's equip your team with the awareness and practices that truly adhere to the stringent regulatory demands while maximizing your Thanks!

$10.000 USD 6 gün içinde