Medical Software Checklist Kit

Abstract: Available
Author: Andy Coster, CCP and Stan Magee CCP (Ret.)
Cover: Available
Customer Set for this product: Medical device firms
Format: Word® (To save money, click here for our PDF version)
ISBN numbers: NA
Language: English
Page count: 1000 +
Provider: SEPT
Sample Pages: NA
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $1,549.00
Product Details

SEPT has packaged 8 documents containing checklists for software standards that medical device firms may need in certifying their medical device products to meet US or EU requirements. A buyer of this kit will add a valuable set of documents to their technical library while saving over 40% off individual prices if purchased separately. The kit is available in either PDF or Word format - the latter format allowing you to easily tailor the documents to your specific organization and/or project.

The kit comes with 32 hours of free consultation from experts that have firsthand knowledge of the underlying standards and processes to which the documents refer. This offer is valid for 60 days after purchase of the product.

Specific SEPT checklist products (documents) included in this kit are:

  1. Checklist for ANSI/AAMI/ISO 13485:2016

  2. Checklist for IEC 62304:2015

  3. Checklist for ISO 9001:2015

  4. Checklist for ISO/IEC 90003:2018

  5. Checklist for UL 1998:2004

  6. Checklist for FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)

  7. Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - May 11, 2005

  8. Checklist for 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 Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software”

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

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 $992. Buying a kit will save you $407 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.

This product supports these Software Engineering processes

  • Acquisition
  • Configuration Management
  • Design
  • Documentation
  • Integration
  • Life Cycle
  • Metrics
  • Quality
  • Requirements Definition
  • Safety
  • Verification And Validation

Customers of this product:

  • AB SCIEX, Canada
  • Bioserve Space Technologies
  • Boston Scientific
  • Chuoutokkyo. Co, Japan
  • CINCI, Italy
  • Electric Fuel Battery Corp
  • Haemonetics Corporation
  • KCI
  • Mechatronic AG, Germany
  • Novo Nordisk Delivery Technologies
  • Valley Lab

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”

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