Claims Development Process

Purpose This document describes the process and provides guidelines as to where claims
are documents, reviewed, approved, and managed.
Scope This document applies to the following Marketing and New Product Management
personnel who are responsible for the identification and management of claims
that will be used externally (non-BSC employees) in the US.
Records Created Not applicable
References 068190, US PSST Material Policy
045247, Market Specification Process
069889, CRM Business Claims
Terminology Claim Any statement directed to the customer or patient by the manufacturer
that communicates product/therapy information.
Product Claim Any statement directed to the customer or patient by the
manufacturer that communicates the product/therapy capabilities, or
characteristics.
Business Claim Any statement that aims to support the demonstration of the
value of the product, project or service to the customer. Often these are
comparative in nature and can be quantitative or qualitative.
Description of
Change
Available at the end of the document.
1. Purpose
This document describes the process to manage a claim based on the type of claim.
2. Claims Development Process
Product Claims, which are identified early in the product development process and are aimed to drive
the design of a product, will be documented and managed within the Marketing Specification Process
(045247) that is within Design Control.
Business Claims, which can be identified at any time of a product or project lifecycle, will be
documented and managed as appropriate. See Reference document CRM Business Claims (069889).
Description of Change
Revision Description of Change
A Initial release. Administrative change on 16 May 2005: added System Review to Sections 3
and 3.1 (Product Claims.)
B Clarified review and approval requirements. Added the term Team Review as needed.
Added process diagrams and updated descriptions of workflow. Re-organized document
flow.
C Added Regulatory Director Signoff to Section 3.3 (inadvertently missed in previous
revisions). Replaced Peer Review with Team Review so as not to be confused with
006646.
D Corrected Claims Requirements Document number to 031718.
E Updated document to reflect new procedures and milestones, team reviews and
supporting data guidelines.
Updated definition of claims and clarified what types of claims should be included in the
Claims Requirements document.
Updated all reference to groups and organizations that no longer exist and updated
new names of current organizations.
Added supporting data guidelines section.
VeriIy revision is current beIore using. Boston ScientiIic ConIidential
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Updated Team and Management Review details and project milestones.
Added a Claims Requirements document Management section.
E Admin Change: Fixed a problem caused by the converter in Section 2.
F Corrected reference to LATITUDE data in section 2.2.10.2
G Updated Table 2 with appropriate milestones and reviewers for each project type.
Changed from Director to Manager level for required management reviewers
Updated Claims Requirement Repository to Windchill from DOCS
H Replace Strategic Marketing with New Product Management throughout document
Remove Design Input (Y/N) reference for Claims Requirement Document in section 2
Change definition of a design input claim (to align with Design Control procedures
definition of a design input) and move to section 2.2 as a note
Added Table 1 for referencing supporting data
Added System Guide as supporting data in section 2.2
Added Reference to US PSST Material Policy (068190)
Provided guidance claims template utilization in Section 1.2.1 and 1.2.2
I Updated Procedure to reflect changes to where specific claims are addressed.


VeriIy revision is current beIore using. Boston ScientiIic ConIidential
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