Tag Archives: Regulations

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Posts Tagged ‘Regulations’


Medical Device Development and Requirements Experts

Posted on: January 27th, 2014 by Lou Wheatcraft No Comments

We are frequently asked whether or not the training we offer is specifically geared to the medical device industry or if our training is generic.  The short answer – our instructors have extensive experience in providing training for the medical … Read More

Requirement Categories – Part 3: Physical Characteristics and Design and Construction Standard Requirements

Posted on: September 19th, 2012 by Lou Wheatcraft No Comments

This is a continuation of Requirement Categories – Part 1: Introduction and Functional/Performance Requirements and Requirement Categories – Part 2: Operational and –ility Requirements. Physical Characteristics: Physical characteristics may be different for different operational phases so think about that. There … Read More

How to Refer to Other Documents within your Requirement Document

Posted on: September 4th, 2012 by Lou Wheatcraft 2 Comments

We were recently asked the following question from one of our clients concerning how to refer to other documents within your requirement document: “One of my co-workers stated that just by listing a document in Section 2.0 “Documents” made all … Read More

Guidelines for Referring to Other Documents in Your Requirements Document

Posted on: September 4th, 2012 by Lou Wheatcraft 2 Comments

This post is a continuation of the previous post:  “How to Refer to Other Documents within your Requirement Document” Standards and Regulations that apply to your project should have been identified by the project during scope definition as drivers and … Read More