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For 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
Download (zip) 1,529 KB, 9 Files (PDF)
Item No.: RCG027BSEP, published January 2010
The Kit includes the following 9 checklists:
plus 4 hours of free consultation for a time period of 60 days after date of purchase
* Checklist for ANSI/AAMI/ISO 13485:2003
* Checklist for ANSI/UL 1998:2004
* Checklist for FDA “General Principles of Software Validation”, released January 2002
* Checklist for FDA “Guidance for the Content of Pre-market submissions for Software Contained in Medical Devices”, edition 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 Cybersecurity 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
Descriptions of checklists
Checklist for ANSI/AAMI/ISO 13485:2003 Medical Dvices
Quality management systems- Requirements for regulatory purposes
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!
Checklist for the application of the standard ANSI/UL 1998:2004 for Software in Programmable Components
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 fuel cell and medical device business community. The UL 1998 standard is focused toward application-specific, non-networked software in a programmable component embedded in a product for which a failure may result in injury to persons. In addition, ANSI/UL 1998 is a reference software standard intended to be used in conjunction with any product specific safety standards that address safety requirements for the identified programmable component and the product hardware. A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, 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.
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.
Checklist for the FDA document “Guidance for the Content of Pre-market submissions for Software Contained in Medical Devices”, edition 2005
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.
Checklist for the FDA 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.
Checklist for the 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
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.
Checklist for IEC 62304:2006 Standard for Medical Device Software
– Software Life Cycle Processes -
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!
Checklist for ISO 9001:2008 Quality Management – Requirements
The 2008 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 9001:2008. 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 9001:2008. 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 9001:2008 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.
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
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