Medical Checklist Kit

New Medical Device Standard Kit: SEPT is pleased to announce a kit of 10 key checklists for medical device firms. Save 50% or more off the individual prices when ordering this collection of medical device standards checklists!

This kit includes:

• Checklist for ANSI/AAMI/ISO Standard 13485:2003.


• Checklist for ANSI/UL 1998:2004.


• Checklist for FDA, General Principles of Software Validation (Release date January 11, 2002).


• Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices:2005.


• Checklist for FDA, Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices as amended by Guidance for Industry, FDA Reviewers and Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software", January 14, 2005.


• Checklist for IEC 60601-1-4 (Edition 1.1 2000-04).


• Checklist for IEC 62304:2006.


• Checklist for ISO 9001:2008.


• Checklist for ISO/IEC 90003:2004.


• IEC 60601-1 Edition 3.0 b Clause 14:2005

Who needs this kit?
This kit is a must for any medical device firm that is selling their products both in the US and the European market

Why
Depending where your customers are located at their could be different standards your product has to meet. You need to have in place all the process and documentations required by these various countries you do business in.

Benefits of buying the kit:
If you bought each checklist separately it would cost you $1191. Buying a kit will save you 50% or $596 dollars. By having this kit your company has the knowledge to have all the artifacts in place to meet all the registrars requirements. You will have at your fingertips all the checklist you need.

Note:

If you bought each checklist separately it would cost you $2990. Buying a kit will save you $1495 dollars!