Achieve ISO 13485 Certification

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.