Template

MDSAP Audit Checklist (FDA)

800+

Use this MDSAP audit checklist to assess how aligned is the company's QMS with that of MDSAP. This digitized MDSAP template is based on the US FDA's MDSAP QMS Internal Assessment Checklist.

With Mitti you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

With Mitti you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

About author

Mitti

Mitti (by SafetyCulture) is the operations system for every site, shift and standard. Trusted by 80,000 organizations in 190 countries, Mitti publishes free checklists, SOP templates, audit checklists and toolbox talk topics that turn paper processes into a digital audit trail. Download one, put it to work on your next inspection or shift, and see why teams keep coming back for more.

Template

MDSAP Audit Checklist for FDA Compliance

This FDA based MDSAP audit checklist helps medical device manufacturers assess the alignment of their quality management system with MDSAP requirements. The template guides reviewers through QMS scope and documentation, leadership and policy, planning, resources and competence, operational planning and control, product and service release, control of nonconforming outputs, performance evaluation, customer feedback and complaints, internal audits, management review, corrective and preventive actions, and continual improvement. Use it to prepare for audits and strengthen compliance.

by Cesar Paredes, from the Community

10+

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Template

MDSAP Audit Checklist FDA

This MDSAP audit checklist helps medical device manufacturers assess alignment of their quality management system with FDA MDSAP requirements. It covers QMS scope, documented information, leadership and commitment, planning, support and competence, internal communication, operations, release of products and services, control of nonconforming outputs, performance evaluation, customer feedback and complaints, internal audits, corrective action and continual improvement, and management review. Use it to structure internal assessments, gather objective evidence, track CAPA, and drive QMS improvements ahead of external audits.

by Lisa Behrens, from the Community

10+

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Template

MDSAP Essential Principles Checklist TGA

This MDSAP Essential Principles checklist based on the Australian TGA helps medical device manufacturers assess conformity across design, construction, and performance. It covers risk management, biocompatibility, contamination control, sterile and non-sterile requirements, packaging and transport, measuring functions, software and programmable systems, electrical and mechanical safety, radiation protection, labeling and information supplied by the manufacturer, instructions for use, and clinical evidence. Includes sections specific to IVD devices and active implantables to support audits and regulatory submissions.

by Bansal Bhawan, from the Community

10+

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Template

MDSAP - Essential Principles Checklist (TGA)

This essential principles checklist template is based on Australia's Therapeutic Goods Administration (TGA) Essential Principles Checklist. Use this checklist to help the company determine conformance with TGA's requirements.

by Mitti

100+

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Template

FDA Inspection: Preparedness Checklist

This FDA Inspection Preparation Checklist can be used to track the preparedness of a site or facility for an upcoming FDA inspection. Managers can use this as an aid to prepare the personnel, site, and documentation for an FDA inspection.

by Mitti

1,000+

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Template

FDA GMP Cosmetics Audit Checklist

This digital GMP Cosmetics Checklist has been built using the SafetyCulture app and based on the FDA's GMP Cosmetic Guidelines. Use this digital GMP checklist to assess your manufacturing compliance with FDA guidelines across aspects of building and facilities, equipment, personnel, raw materials, production, lab controls, record keeping, labelling and complaints. Use SafetyCulture to take notes and photo evidence of non-compliance. Automatically calculate your audit score based on the responses and generate a complete report without leaving your manufacturing facility. Save all your reports securely in the cloud.

by Mitti

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MDSAP Audit Checklist (FDA)

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