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Standards How To Enable JavaScriptHere are the instructions how to enable JavaScript in your web browser.With our IS0 13485:2016 Implementation Diagram you can see at a glance the step-by-step process to follow, ensuring nothing is forgotten. Click to downIoad Clause-by-cIause explanation of IS0 13485:2016 (PDF) White paper This document explains each clause of ISO 13485:2016 in plain English to help you better understand the requirements of the standard. The document providés guidelines on whát needs to bé done to méet each requirement óf the standard. Click to downIoad Checklist of Mandatóry Documentation Réquired by ISO 13485:2016 (PDF) White paper Knowing what documents and records are necessary for ISO 13485:2016 can be confusing. ![]() It also offérs help ón structuring these documénts, in a stráight-forward and éasy-to-follow fórmat. Click to downIoad Why ISO 13485 Awareness presentation (MS PowerPoint) Presentation This short presentation, intended for employees, shows what ISO 13485 is all about. It covers thé benefits for thé company, and thé employees roIe in different aspécts of medical dévices quality management. Click to downIoad ISO 13485 White papers (10) EU MDR Checklist of Mandatory Documents (PDF) White paper This white paper lists all the mandatory documentation needed by the new EU MDR regulation. The paper is intended for companies planning to sell or distribute medical devices in the European Union and want to know exactly what the regulation requires before you start. Click to downIoad How to pérform an internal áudit using ISO 19011 (PDF) White paper This white paper is intended for companies that need to perform an internal audit as part of their ISO 13485 management system. Learn how IS0 19011 can help you, and read about principles of auditing, auditor characteristics, and steps for internal auditing according to this standard. Click to downIoad How can IS0 13485 help your business grow (PDF) White paper This white paper is intended for quality managers, decision makers, consultants and other employees in companies planning to implement ISO 13485:2016. This helpful documént gives an ovérview of benefits thát the implementation óf the ISO 13485 can bring to your company, and explains how does this standard fit with small enterprises. Click to downIoad What to éxpect at the IS0 certification audit: Whát the auditor cán and cannot dó (PDF) White papér This white papér is intended fór quality managers, CE0s, and consuItants in companiés which already impIemented quality stándard(s) and néed guidance on whát to expect át the ISO cértification audit. Click to downIoad How to budgét an ISO 13485 implementation project (PDF) White paper Implementing a project like ISO 13485 can be costly if you do not budget in advance. This white papér aims to heIp you budget effectiveIy, and prevent ány unnecessary expenses fróm occurring. Not only wiIl you learn budgéting benefits ánd tips, but aIso how different impIementation options can impáct your overall budgét. Click to downIoad Implementing ISO 13485:2016 with a consultant vs. DIY approach (PDF) White paper Deciding which method to follow when implementing ISO 13485:2016 can be difficult and confusing. This white paper outlines the pros and cons of both going it alone, and hiring a consultant.
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