PTC Windchill Medical Device Template Optimizes Regulatory Compliance Process
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PTC Windchill Medical Device Template Optimizes Regulatory Compliance Process

Leading manufacturer of medical devices will rely on the PTC(R) Product Development System to manage mechanic, electronic and software design data

NEEDHAM, Mass.—(BUSINESS WIRE)—Jan. 17, 2006— PTC (Nasdaq: PMTC), the Product Development Company(TM), today announced that Stryker Navigation based in Freiburg (Germany), is deploying Windchill PDMLink(TM) for product lifecycle management (PLM) in conjunction with the Windchill Medical Device Template . The PTC Product Development System enables Stryker Navigation to optimize 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.

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 commercialized in different geographies.

"Applying the Medical Device Template brings more transparency to our product development processes, especially when it comes to coordinating 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 Furthermore, the solution reduces the number of iterations and modifications caused by out-of-date design information from different sources," said Klaus Welte, Vice President R&D, Stryker Navigation.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&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."

About Stryker

Stryker Corporation is one of the world's leading medical device companies with the most broadly-based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants that are used in joint replacement, trauma, craniomaxillofacial and spine surgeries; orthobiologics; operating room and interventional pain products; surgical navigation, endoscopic, communications and digital imaging systems; as well as patient handling and emergency medical equipment. Stryker also provides outpatient physical therapy services in the United States.

The Company's navigation systems offer surgeons the ability to use GPS-like technology to accurately track in real time where the instruments are relative to the patient anatomy during an operation. By combining computers, infrared cameras and wireless instruments, these systems provide surgeons with equipment to help enhance accuracy in Neuro, ENT, Joint Replacement, Spine and Trauma surgical procedures. The Company's website address is http://www.stryker.com

About PTC

PTC (Nasdaq: PMTC) provides leading product lifecycle management (PLM), content management and dynamic publishing solutions to more than 40,000 companies worldwide. PTC customers include the world's most innovative companies in manufacturing, publishing, services, government and life sciences industries. PTC is included in the S&P 500 and Russell 2000 indices. For more information on PTC, please visit http://www.ptc.com.

Except for the historical information contained herein, matters discussed in this news release may constitute forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those projected. These include: the successful development and integration of the technology necessary to offer an integrated Product Development System that adequately responds to the evolving design, data management and regulatory testing requirements of customers within the medical device industry; continued growth in the adoption of PLM solutions by medical device customers; and PTC's ability to extend our solutions to vertical industries beyond the discreet manufacturing verticals traditionally served by PTC; as well as other risks and uncertainties detailed from time to time in reports filed by PTC with the Securities and Exchange Commission, including the Company's most recent reports on Form 10-K and 10-Q. The announcement of any particular deployment of PTC software is not necessarily indicative of the timing of recognition of revenue therefrom or the level of revenue for any particular period.

PTC, The Product Development Company, Product First, Pro/ENGINEER, Wildfire, Windchill, Windchill PDMLink and all PTC product names and logos are trademarks or registered trademarks of Parametric Technology Corporation or its subsidiaries in the United States and in other countries.



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