Template

MDSAP Essential Principles Checklist TGA

by Bansal Bhawan, from the Community

10+

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.

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Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

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 SafetyCulture
Downloads: 100+
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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
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Template
MDSAP Audit Checklist (FDA)
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.
by SafetyCulture
Downloads: 800+
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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
Downloads: 0
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MDSAP Essential Principles Checklist TGA

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