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November 2010

Karen M. Becker

Assessing the Proposed Changes to the US FDA's 510(k) Programme

 by Karen M. Becker
 PhD, Founder and Chief Executive Officer of Becker & Associates Consulting, Inc.

The paradigm applied for providing reasonable assurance that every medical device marketed in the US is safe and effective is the most stringent in the world. In accordance with current applicable law, regulations, guidance and policy, these critical healthcare products are required to be designed, tested, manufactured, cleared and marketed in compliance with a detailed series of rigorous requirements and standards.

The 510(k) process has nonetheless come under criticism in recent years, with some constituencies (including the FDA) proposing fundamental changes to the regulatory paradigm.

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Dr. John McLane

Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company

by Dr. John McLane
VP Clinical and Regulatory & COO, Clinquest

A common biotech business model is to have a lean and fast virtual organization. These organizations are established with experienced professionals who have a wide breadth of entrepreneurial experience and experience within the pharmaceutical, biotechnology or even medical device sectors. These organizations also have innovative products that are to be developed to the next inflection point, which is usually a step to reduce further developmental risk. The product can then be moved on toward regulatory development or licensed to a larger organization. Conducting early phase I or II (or a combination of both) clinical trials for the innovative product is often the mandate of these types of virtual companies. With limited human resources the organization must outsource many of the tactical and operational activities. For a clinical trial this will include the activities associated with manufacturing, distribution, regulatory, clinical operations, and safety evaluations.

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BARQA Annual Conference
November 2-5, 2010, Leeds, UK

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February 7-10, 2011, Anaheim, CA

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Did you know that device manufacturing companies can use the new FDA device inspections database as a supply chain resource? According to FDANews however, the process of managing and supporting suppliers has just become a lot simpler! With the FDA's new device inspection database, device manufacturers can access information regarding device inspections, access warning letters, look up device types and learn more about specific manufacturing facilities.
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