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    Axendia is a leading consulting and strategic advisory firm focused on the Life-Sciences and Healthcare markets.

    Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues.

    We serve the complete Life-Science Eco-System including Life-Science Organizations, Technology & Service Providers and the Investment community.

    Axendia professionals offer a unique combination of hands-on experience coupled with strategic vision. Our consultants have an average of 20 years Life-Science experience working with organizations ranging from startups to Fortune 100.

    We contribute to our client’s success by helping them navigate the ever changing Business, Technological and Regulatory landscape in the Life-Sciences industry.

    Let Axendia provide you the insight you need to make the right decisions in this complex and highly regulated Industry.

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Syndication

axendia

Innovative Strategies to Integrate Development, Manufacturing and Commercialization of Customized Medical Devices

July 25, 2007
1:00pm EDT

Speakers:
Karim Lokas, Camstar
Daniel R. Matlis, Axendia
David Rubin, PTC

The integration of PLM solutions with MES (Manufacturing Execution Systems) promises to tie the product development process to the physical world of production which will dramatically improve both product innovation and design for manufacturability, especially for manufacturers of highly complex products. Manufacturers will be able to realize the benefits of Shorter NPI and time to volume, higher product quality and lower production costs due to a reduction in defects and products scrapped. For highly regulated industries like Medical Devices, closing the loop between ‘As designed’ and ‘as built’ with full traceability into product and process variability, change management and root cause analysis will greatly enhance compliance with strict standards and federal regulations by building quality in by design.

In this session, you will learn about:

• Integrating the Development/Engineering cycle with Manufacturing Process Design
• Effectively releasing Product/process data during New Product Launches
• Address comprehensively DMR (Device Master Record) and DHR Device History Record) requirements
• Implementing an effective Continuous Improvement loop between Manufacturing and Engineering

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Published Wednesday, July 11, 2007 5:40 PM by axendia
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About axendia

Axendia is a leading consulting and strategic advisory firm focused on the Life-Sciences and Healthcare markets.

Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues.

We serve the complete Life-Science Eco-System including Life-Science Organizations, Technology & Service Providers and the Investment community.

Axendia professionals offer a unique combination of hands-on experience coupled with strategic vision. Our consultants have an average of 20 years Life-Science experience working with organizations ranging from startups to Fortune 100.

We contribute to our client’s success by helping them navigate the ever changing Business, Technological and Regulatory landscape in the Life-Sciences industry.

Let Axendia provide you the insight you need to make the right decisions in this complex and highly regulated Industry.