Product category:
PLM and collaboration software
News Release from: PTC - Parametric Technology (UK) | Subject: Windchill PDMLink and Medical Device Template
Edited by the Engineeringtalk Editorial
Team on 19 January 2006
PLM software aids medical device
compliance
Stryker Navigation, based in Freiburg (Germany), is deploying Windchill PDMLink for product lifecycle management (PLM) in conjunction with the Windchill Medical Device Template.
Stryker Navigation, based in Freiburg (Germany), is deploying Windchill PDMLink for product lifecycle management (PLM) in conjunction with the Windchill Medical Device Template The PTC product development system enables Stryker Navigation to optimise the regulatory compliance process by establishing a common product data management platform for mechanical, electronic and software design with integral processes for automated design history file (DHF)- and device master record (DMR)-reporting, digital signature procedures, approval workflows and audit reports
This article was originally published on Engineeringtalk on 13 Mar 2002 at 8.00am (UK)
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Stryker chose the PTC product development system as its PLM backbone because it supports the processes to achieve compliance with standards from the US Food and Drug Administration (FDA).
The combination of Windchill PDMLink and the Medical Device Template replaces manual documentation processes and allows companies to automatically trace and record product data over the whole product lifecycle.
This is a requirement by the FDA and other national authorities before a product can be commercialised in different geographies.
"Applying the Medical Device Template brings more transparency to our product development processes, especially when it comes to co-ordinating the mechanical, electronics and software design".
"Furthermore, the solution reduces the number of iterations and modifications caused by out-of-date design information from different sources", said Klaus Welte, Vice President R and D, Stryker Navigation.
"Using Windchill as the backbone for our product development system will help us to shorten time to market by providing the tools to obtain FDA compliance earlier in the development process", said Dr Jurgen Pross, Director Product Development R and D, Stryker Navigation.
"We expect to see the ROI within the first year following the roll-out".
"Life sciences customers face increasing pressures in their businesses to speed time to market while meeting more stringent regulatory demands", said Mark Dorsett, Vice President Portfolio Consulting.
"We are helping innovative customers like Stryker overcome this challenge so that they can spend more time developing great products and less time on administrative tasks".
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