"Many companies appear to lack a detailed awareness of what the regulations require. With the uncertainty of what needs to be done, companies often layer in far more checks and balances than they need, which drives up costs. Companies that can streamline their compliance needs are more competitive and flexible. I am supporting this survey to help the industry understand what we can do to gain agility and profitability yet still be in compliance," says Larry Dube, a veteran executive of the medical device industry.
In addition to Dube, Industry Council members include Andrew Dancan, Director of Enterprise Resource Planning at Cardiovascular Systems, Inc.; and Carl Heeder, Director, ERP Systems at IDEV Technologies, Inc.; and other managers from an array of medical device and component manufacturing and production companies. These seasoned professionals have added depth and ensured that hot topics are included effectively.
Andrew Dancan, Director of ERP for Cardiovascular Systems, sees important needs looming: "Our company is now public and subject to Sarbanes-Oxley. Now that we are heading into the coronary area, we will also need to incorporate 21 CFR Part 11 electronic signatures as well. We must make sure we comply and ship perfect products with as little overhead as possible. So learning best practices is important for us."
The Industry Council has helped to ensure that the study is as relevant as possible by guiding the selection of study topics and will also confirm the quality of findings in the final report. The Council vetted the on-line survey to ensure that it covered the most important topics to identify operational metrics that really matter to the success of the overall business. The survey is now open for response through April 30 at this link: http://bit.ly/Hh56QA.
Any individual working for a company that makes medical devices or supplies materials to this industry in companies in every country in the world and across all production industries is requested to spend 15 minutes responding to the survey. As a thank-you for participating, respondents receive the full findings report for this study when it is available.
The Industry Council represents companies in a variety of medical device industry segments including cardiovascular, radiology, plastic components, oncology, ENT, orthopedics, and women's health. These individuals have all been involved in the deployment of operational metrics systems that drive appropriate behavior in medical device manufacturing plants.
A sneak preview of the findings will be presented at the Medical Device and Manufacturing East show May 21-24 in Philadelphia, PA. Lead researcher Julie Fraser will share data from the study to highlight best practices and approaches for success. She will also be available to answer questions and discuss issues with attendees. UBM Canon Medical Group is supporting this research.
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