Medical Device (ISO 13485)

The existing standard for medical devices; the ISO 13485 is a core Quality Management System for this industry. It is aimed at setting standards for high medical devices safety which medical devices companies have to match to meet customer expectations.

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ISO 13485 Gap Analysis Toolkit

FileSize : 328 KB
Format : Word
Language : English
Provider : 13485 Store
ISO 13485 Gap Analysis Toolkit - A detailed ISO 13485 GAP Analysis checklist (MS Word) with guidance on what to look for to evaluate your current processes and their compliance to the ISO 13485 Requirements.
P10000
Your Price: US$59.00



ISO 13485 Quality Manual

FileSize : 296 KB
Format : Word/pdf
Language : English
Provider : 13485 Store
ISO 13485 Quality Manual - Save the time and resources required to design and document an ISO 13485 Quality Management System. The 13485 Store has created most of it for you
P10001
Your Price: US$97.00



Intro to ISO 13485 Presentation Materials

FileSize : 1 MB
Format : PowerPoint/pdf
Language : English
Provider : 13485 Store
Intro to ISO 13485 Presentation Materials – Intro to ISO 13485 PowerPoint and Presentation Materials reviews ISO 13485 and the steps for implementation. Includes trainer & student guides to educate management, employees, customer or other groups on ISO 13485.
P10002
Your Price: US$85.00



ISO 13485 Internal Auditor Checklist

FileSize : 408 KB
Format : PowerPoint/Word
Language : English
Provider : 13485 Store
ISO 13485 Internal Auditor Checklist - This package includes all the tools you need to establish your Internal Audit Program. The documented procedure has been used and proven in registered companies across the globe.
P10003
Your Price: US$95.00



ISO 13485 Internal Auditor Training

FileSize : 1.6 MB
Format : PowerPoint, Word & pdf files
Language : English
Provider : 13485 Store
ISO 13485 Internal Auditor Training - This complete training package provides you with the course content and information you need to present an interactive training for your Internal Audit Team.
P10004
Your Price: US$495.00



ISO 13485 Quality Manual & Procedures Package

FileSize : 968 KB
Format : Word/Excel
Language : English
Provider : 13485 Store
ISO 13485 Quality Manual & Procedures Package - Building your QMS is a cornerstone of any successful ISO 13485 Registration. But why take the risk of starting from scratch? With our fully-customizable Quality Manual and Procedures package you will have all the processes and documents you need.
P10005
Your Price: US$397.00



ISO 13485 Small Business Package

FileSize : 1.54 MB
Format : Word/Excel/PPT
Language : English
Provider : 13485 Store
ISO 13485 Small Business Package – It includes everything a small business needs for certification: Manuals & Forms, Checklists and training.
P10006
Your Price: US$697.00



ISO 13485 All in One Documentation & Training Package

FileSize : 4.63 MB
Format : Word/Excel/PPT
Language : English
Provider : 13485 Store
ISO 13485 All in One Documentation & Training Package - The 13485 All in One Package includes everything you need to prepare for certification: Manual, Procedures & Forms, Checklists, Employee & Internal Auditor Training. Includes support!
P10007
Your Price: US$997.00



ISO 13485 PC Based Employee Training

FileSize : 12.2 MB
Format : Application (exe file)
Language : English
Provider : 13485 Store
ISO 13485 PC Based Employee Training - This ISO 13485 Training course provides introductory ISO 13485 training for employees, and includes audio, quizzes and a certificate.
P10008
Your Price: US$495.00



ISO 13485 Workbook & Training

FileSize : 7 MB
Format : Word/pdf/PPT
Language : English
Provider : 13485 Store
ISO 13485 Workbook & Training - The first step in your ISO 13485 project is to define and build a Quality Management System (QMS) according to the requirements of the ISO 13485 standard.
P10009
Your Price: US$99.00


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