I will prepare documents for iso 13485 to pass the audit

Are you looking to get ISO 13485 certification or improve your Medical Device Quality Management System?

I will help you develop, audit, and implement a complete ISO 13485:2016 QMS tailored to your medical device company ensuring compliance with EU MDR, FDA, TGA & MDSAP.

BASIC (Internal Audit):

Conduct a professional ISO 13485 internal audit, identify gaps, and provide a detailed audit report with corrective action recommendations.

STANDARD (Documentation Pack):

Deliver complete ISO 13485 documentation, including Quality Manual, SOPs, forms, templates, and records ready for certification or regulatory inspection.

PREMIUM (Full QMS Program):

End-to-end ISO 13485 implementation program from gap analysis, documentation, internal audit, risk management, to certification support and regulatory alignment with MDR/FDA.

Medical Device QMS expert

Compliant with MDR, FDA, and TGA requirements

Audit-ready documents and templates

Lets make your ISO 13485 certification process smooth, fast, and fully compliant!

Note: It is highly recommended to discuss the project in chat or zoom meeting before placing the order.