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December 2012

Cindy Fazzi

Developing a QMS: Should You Buy or Build?

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

Either way, an organization must ask itself: Is it more cost-effective to build a homegrown system or to buy a proven and validated QMS? Which option is cost-effective not just initially but over the long haul?

"Building" a QMS means you will develop the system in-house, possibly with the help of consultants. You may write your own software from scratch, or use templates as a framework. Writing your own software gives you control over the development and expansion of the system. In terms of cost, you can build the system piecemeal, as funds and other resources become available.

While building offers flexibility, there are key issues involved. First, you run the risk of not covering all the bases when it comes to regulatory requirements. Second, you must have staff members with the right skills and experience who can devote themselves to the project. Otherwise, any delay might make the system obsolete before it is completed. Third, even though a homegrown system seems inexpensive, the cost can quickly add up when you consider the number of people and the time and effort the project would require. It is not uncommon for organizations to start building a system then abandoning it because unexpected changes have made the project moot. Those organizations end up buying anyway.

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An Engineer Takes on the Medical Device Regulatory Process, Part I

by Karen Brentnall
Senior Quality Engineer, Stratos Product Development

Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While it’s a common goal, the medical device regulatory approval process can be confusing for design and development engineers. They may hear terms such as "safety agency," "CE mark," "Notified body," "510K" and "PMA" tossed around by quality and regulatory professionals. Although these terms are likely to be somewhat familiar, their true meanings and proper application are not always clear to many of us who are part of the development process.

To commercialize any medical device, the appropriate regulatory process must be followed. This process varies depending on the country where the device is intended to be marketed and sold. So, how do medical device companies obtain approval of their products in Europe, in the U.S., and in other countries around the world? This three-part series will address what engineers need to know from a design and development standpoint.

To sell a medical device on the European market, it must first be CE-marked. A CE mark on a medical device means that the product meets the essential requirements designated in Annex I of the Medical Device Directive (MDD) 93/42/CE. The MDD is a European Regulation which is intended to harmonize the laws within the European Union which pertain to medical devices.

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Did you know that if the 2.3% medical device excise tax fails repeal, the industry will need about $2.5 billion to comply with the next tax levy? Medtech industry lobby AdvaMed released the results of its latest analysis of the impact of the excise tax, which suggests that next year's total federal tab may be nearly 30% larger than the industry currently pays.
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