For Medical Device Firms
Checklists for compliance with the following new
software standards
IEC 62304 and ISO
13485:2015
Below are the key checklists for compliance with
the major software
"Medical Device" standards
New
IEC 62304:2015 Checklist
This Checklist is for the application of
the medial device Standard IEC
62304:2015 Medical Device Software
Software Life Cycle Processes -
including Amendment 1. This
checklist defines clearly the
.............
New
ISO
13485:20016 Software Requirements
Checklist for ISO 13485:2016 Medical
devices - Quality management systems-
Requirements for software related
regulatory purposes. Being a stand-alone
quality system standard for medical ...........
Checklist
for FDA General Principles of
Software Validation
Evidence product checklist for the FDA
document General Principles of
Software Validation - Final Guidance
for Industry and FDA staff. The
checklist uses a classification scheme
of physical evidence comprised of
procedures, plans ............
FDA
Guide, Pre-market Submissions, Software
in Medical Devices
This is a Checklist for the application
and compliance with the document FDA
Guidance for the Content of Pre-market
Submissions for Software Contained in
Medical Devices. This is a must
have for all quality managers
..........
FDA
Off-the-Shelf Software in Medical
Devices, Checklist
This new edition of the checklist has
been updated to reflect the suggested
compliance with the document
Compliance on Cybersecurity for
Networked Medical Devices Containing
Off-the Shelf (OTS) Software"
........
ANSI/UL
1998:2004 Checklist
This checklist was updated to include
Revision 1 of this major software
engineering document "ANSI/UL 1998
Standard for Software in Programmable
Components".
This standard is used by the
............
ISO/IEC
90003:2014 Checklist
Checklist for the software engineering
quality standard: ISO/IEC 90003:2014;
Software engineering - Guidelines for
the application of ISO 9001:2008 to
computer software. The Checklist uses
a classification scheme .........
ISO
9001:2015 Evidence Product Checklist
Checklist for the standard ISO
9001:2015 Quality Management
System Requirements. The 2015 version of
ISO 9001 has proved to be a landmark
quality standard for the international
business community ............
These 8
products are also available in Kit format with saving of $ 50%
of the individual price
Data
Security
To
protect your company
and customers it is
important to meet the
requirements of the
International Data
Security Standards
Below
are the links to 3
checklists that will help
you to meet this goal:
