Evidence
Product Checklist for
IEC Standard 60601-1-4
Edition 1.1 2000-04 Medical
Electrical Equipment
Part 1: General Requirements
for Safety
Part 4. Programmable
Electrical Medical Systems
Description
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”. This revised version includes
over 100 additional physical evidence items that enable compliance, (either
as required or recommended items). The checklist uses a classification
scheme of physical evidence comprised of procedures, plans, records, documents,
audits, and reviews. For medical device firms, the use of these checklists
will save time and money, and may aid in meeting certain governmental requirements.
ISO/IEC 12207 Software
Life Cycle Processes
Evidence Product Checklist
includes Amendment 1
and Amendment 2
Description
Checklist for the 2004 edition
of the software engineering standard ISO/IEC 12207, Software Life Cycle
Processes, including Amendment 1 and Amendment 2 of the standard. The Checklist
ensures that all the required documentation for your organization is identified.
It clearly defines the procedures, plans, records, documents, audits and
reviews that are required or suggested, including all the required items
that are necessary to demonstrate evidence of conformity. This is a “must
have” for all quality managers involved in ISO/IEC 12207.
The Checklist uses a classification
scheme of physical evidence comprised of procedures, plans, records, documents,
audits, and reviews. It includes many suggestions for items that are not
specifically required by the standard but “hinted at” in the text. This
standard calls out or suggests over 475 items of physical evidence. The
Checklist clarifies what is required for compliance by providing an easy-to-use
product evidence list that will assist any software organization in meeting
the requirements of this important standard.
Evidence Product Checklist
for the FDA document
General Principles of
Software Validation
Final Guidance for Industry
and FDA Staff
Description
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, documents,
audits, and reviews. The checklist clarifies what is required for compliance
by providing an easy-to-use product evidence list that will assist any
software organization in meeting the requirements of this standard. Use
of the checklist will save time and money, and may aid in meeting certain
governmental requirements.
Evidence Product Checklist
for the FDA Document “Guidance for the Content of Pre-market Submissions
for Software Contained in Medical Devices”
Description
Checklist for the software
engineering medical device guidance document: FDA Guidance for the Content
of Pre-market Submissions for Software Contained in Medical Devices.
The checklist provides an easy-to-use classification scheme of physical
evidence comprised of procedures, plans, records, documents, audits, and
reviews. The checklist clarifies what is required for compliance through
a product evidence list that will assist any software organization in meeting
the requirements of this FDA document. Use of the Checklist will save time
and money, and may aid in meeting certain governmental requirements.
Evidence Product Checklist
ISO 9001:2000 Quality
Management – Requirements
Description
Checklist for the standard
ISO 9001:2000 - Quality Management System Requirements. The 2000 version
of ISO 9001 has proved to be a landmark quality standard for the international
business community. However, in many occasions it is still difficult to
interpret what is required and what is suggested in many areas. The generic
nature of a standard that applies to software, hardware, process materials
and services makes it difficult to apply in any one situation. But, help
is available with this new checklist for ISO 9001:2000. This is a “must
have” for all quality managers and engineers involved in ISO 9001 certification,
presenting all the required items that are necessary to demonstrate evidence
of conformity to ISO 9001:2000. It includes many suggestions for items
that are not specifically required by the standard but “hinted at” in the
text. The checklist is particularly useful for anyone updating their quality
management system to the newest version of the ISO 9001 standard as an
easy way to show gaps in meeting the new requirements. For auditors, especially
as part of pre-assessment of an organization to ISO 9001:2000 requirements,
the checklist is an essential tool. The checklist uses a classification
scheme of physical evidence comprised of procedures, plans, records, documents,
audits, and reviews. This standard calls out or suggests over 475 items
of physical evidence. The checklist clarifies what is required for compliance
by providing an easy-to-use product evidence list that will assist any
organization to meet the requirements of this important standard. |
Evidence
Product Checklist for
ANSI/AAMI Standard SW68
Medical Device Software-
Software Life Cycle Processes
Description
Checklist for the standard
ANSI/AAMI SW68. This checklist uses a classification scheme of physical
evidence comprised of procedures, plans, records, documents, audits, and
reviews. It identifies over 350 pieces of physical evidence. This checklist
clarifies what is required for compliance with the standard by providing
an easy-to-use product evidence list that will assist any software organization
in meeting the requirements of this standard. For medical device firms,
use of the checklist will save time and money, and may aid in meeting certain
governmental requirements.
IEC
62304:2006
Standard
for
Medical
Device Software
– Software Life
Cycle Processes -
Evidence
Product Checklist
Description
This Checklist is for the application of the 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 prepared by analyzing each clause of the standard for the key
words that signify a policy, procedure, plan, record, document, audit, or
review. The checklist provides an easy-to-use classification scheme of
physical evidence comprised of procedures, plans, records, documents, audits,
and reviews. The number required
or suggested by this document is over 325 items. This checklist reflects requirements for artifacts (procedures, plans,
records, documents, audits, reviews).
The Checklist clarifies what is required for compliance through a product
evidence list that will assist any software organization in meeting the
requirements of this standard.
The purchase of the checklist includes four hours of free consultation
during 60 days after date of purchase, concerning questions about the standard
and the checklist. The checklist is a quality product at a reasonable price!
Evidence Product Checklist
for the FDA Document “Guidance for Industry, FDA Reviewers and Compliance
on Off-the-Shelf Software Use in Medical Devices”
Description
Checklist for the software
engineering medical device guidance document: Guidance for Industry,
FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices.
The checklist provides an easy-to-use classification scheme of physical
evidence comprised of procedures, plans, records, documents, audits, and
reviews. The checklist clarifies what is required for compliance through
a product evidence list that will assist any software organization in meeting
the requirements of this standard. Use of the Checklist will save time
and money, and may aid in meeting certain governmental requirements.
EVIDENCE PRODUCT CHECKLIST
ANSI/AAMI/ISO Standard
13485:2003 Medical Dvices
Quality management systems-
Requirements for regulatory purposes
Description
Checklist for ANSI/AAMI/ISO
Standard 13485:2003 Medical devices - Quality management systems- Requirements
for regulatory purposes ISO 13485. Being a “stand-alone” quality system
standard for medical devices, this standard represents a major change in
concept and goes much further than ISO 9001 in requirements for documentation.
The checklist is an invaluable tool to ensure that all the required documentation
is identified for an organization. It clearly defines the procedures, plans,
records, documents, audits and reviews that are required or suggested.
This checklist is a “must have” for all quality managers involved in ANSI/AAMI/ISO
Standard 13485:2003 certification, presenting all the required items that
are necessary to demonstrate evidence of conformity. It includes many suggestions
for items that are not specifically required by the standard but “hinted
at” in the text. The checklist uses a classification scheme of physical
evidence comprised of procedures, plans, records, documents, audits, and
reviews. This standard calls out or suggests over 300+ items of physical
evidence. The checklist clarifies what is required for compliance by providing
an easy-to-use product evidence list that will assist any organization
to meet the requirements of this important standard. Using the checklist
saves time and money, and will aid in meeting certain regulatory requirements!
ISO/IEC 90003:2004
EVIDENCE PRODUCT CHECKLIST
Software engineering
- Guidelines for the application of ISO 9001:2000 to computer software
Description
Checklist for the software
engineering quality standard: “ISO/IEC 90003:2004; Software engineering
- Guidelines for the application of ISO 9001:2000 to computer software”.
The Checklist uses a classification scheme of physical evidence comprised
of procedures, plans, records, documents, audits, and reviews. This checklist
defines: all required items, all items required by ISO/IEC 12207 Software
Life Cycle Processes as referenced by ISO/IEC 90003:2004, and suggested
items to comply with best practice in the software engineering profession.
This checklist clarifies what is required for compliance by providing an
easy-to-use product evidence list that will assist any software organization
in meeting the requirements of the standard. |
