October 1, 1997

3 Min Read
Finding the Right Off-the-Shelf Requirements Management Tool

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1997 Column

DESIGNER'S TOOLBOX

Six programs help design engineers with requirements tracking, modeling, analysis, and other tasks necessary for design control.

Using a requirements management system (RMS) can help companies address the design input requirements of ISO 9000 and FDA's quality system regulation. If the system is well designed and executed, it can reduce development time and costs by reducing the number of design iterations. Such success depends on the tools you choose.

A number of off-the-shelf requirements management products are available to satisfy the needs of an RMS. Because of space limitations, this discussion is limited to only six (Table I). While not comprising an exhaustive list, the products represent the range of approaches to requirements management. A summary of the features and functions of these products is shown in Table II.

Company

Product

Web Site

Integrated Chipware

RTM

Quality Systems & Software

Doors

TD Technologies

Slate

Ascent Logic

RDD-100

Vitech

Core

i-Logix, Inc.

Statemate



Table I. The manufacturers of RMS tools and their Web site addresses. None of the products surveyed had any interface to project management software.

Function

RTM

Doors

Slate

RDD-100

Core

Statemate

Sources

Y

Y

Y

Y

Y

N

Requirements

Y

Y

Y

Y

Y

Y

Analysis and modeling

N

E

Y

Y

Y

Y

Safety analysis

Y

N

N

N

N

N

Interface control documents

Y

Y

Y

Y

Y

Y

Specifications generator

Y

Y

Y

Y

Y

Y

Compliance matrix generator

Y

Y

Y

Y

Y

E

Management report generator

Y

Y

Y

Y

Y

N

External interfaces

Y

Y

Y

Limited

Y

Limited

Learning curve (weeks)

1

1

1

3­8

1

2­4

Cost per seat ($0,000)

7

5­14

15

21

8

25

Platform (PC/Mac/Unix)

PC/U

PC/U

PC/U

PC/M/U

PC

PC/U



Table II. The features and functions of requirements management tools. Y = Yes, N = No, and E = External interface.

Requirements-Tracking Products. If your RMS involves large numbers of requirements sources, multiple levels of specifications, and requirements traceability, Doors or RTM may fit your needs. These products are good general-purpose requirements databases and can serve as a front end to a complete RMS. Neither of these products includes an analysis and modeling engine, but each provides interfaces to modeling tools like Statemate.

Requirements and Modeling Products. If your RMS consists of a combination of complex requirements and rapid system modeling in order to validate requirements, Slate, Core, or RDD-100 may help you keep organized. All these tools include both requirements and modeling components. RDD-100 has a significant learning curve but is a very powerful management tool.

Modeling and Simulation Products. If your RMS focuses on detailed product simulations and virtual prototyping, Statemate is a product that can handle these needs as well as interface with other products. It is a powerful function- and behavior-modeling tool with interfaces to requirements-tracking tools like RTM and Doors.

For a detailed comparison of these and other RMS products, check the International Council on Systems Engineering (INCOSE) Web page. According to the site, INCOSE is "an international organization formed to develop, nurture, and enhance the interdisciplinary approach and means to enable the realization of successful systems." INCOSE works with industry, academia, and government.

Edward V. LaBudde is managing director of LaBudde Systems (Westlake Village, CA).

Copyright ©1997 Medical Device & Diagnostic Industry

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like