FDA
Requirements Checklist Kit
for Medical Device Firms forr ANSI/AAMI/ISO
13485, ANSI/UL 1998, IEC 60601-1-4, IEC 62304,
ISO 9001, ISO/IEC 90003,
FDA Pre-market Submissions, Software
Validation, Off-the-Shelf Software,
Cybersecurity
includes
the following checklists
ANSI/AAMI/ISO
13485:2003 Requirements
Checklist for ANSI/AAMI/ISO Standard
13485:2003 Medical devices - Quality
management systems- Requirements for
regulatory purposes. Being a
“stand-alone” quality system
standard for medical devices .....
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, records .........
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"
..........
IEC
62304:2006 Checklist
This Checklist is for the application of
the medial device Standard IEC
62304:2006 Medical Device Software –
Software Life Cycle Processes This
checklist defines clearly the artifacts
required by this standard. This
checklist was ..........
ISO/IEC
90003:2004 Checklist
Checklist for the software engineering
quality standard: “ISO/IEC 90003:2004;
Software engineering - Guidelines for
the application of ISO 9001:2000 to
computer 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 .....
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
........
IEC
60601-1-4 Checklist
New and updated checklist for the
2000-04 version of IEC 60601-1-4
”Medical Electrical Equipment, part I:
General Requirements for Safety, and
part 4: Collateral Standard:
Programmable Electrical Medical
Systems” .........
ISO
9001:2008 Evidence Product Checklist
Checklist for the standard ISO 9001:2008
- Quality Management System
Requirements. The 2008 version of ISO
9001 has proved to be a landmark quality
standard for the international business
community ..........
