What are the 4 Key Elements in Compliance Management Software?

By Tim Lozier

Being in compliance means operating your business in a manner that means less risk, better quality, safety and governance. Compliance management software is designed to help foster this concept, so what do you need it to be?

Being in compliance means operating your business in a manner that means less risk, better quality, safety and governance. Compliance management software is designed to help foster this concept, so what do you need it to be?

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Are you Ready for a Notified Body Unannounced Audit?

By Sangita Viswanathan

There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.

There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.

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Innovative X-ray Technology – for Improved Breast Cancer Diagnosis

The accuracy of mammography is often not good and requires improvement. One source of hope to address this includes phase-contrast imaging, a procedure based on x-rays which is of special interest for breast cancer diagnosis, and has wider applications.

The accuracy of mammography is often not good and requires improvement. One source of hope to address this includes phase-contrast imaging, a procedure based on x-rays which is of special interest for breast cancer diagnosis, and has wider applications.

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Recognizing the Value of PLM in Health Sciences

How stakeholders in a global value chain can create an innovation environment that leverages product lifecycle management to drive today’s most important health sciences business initiatives.

How stakeholders in a global value chain can create an innovation environment that leverages product lifecycle management to drive today’s most important health sciences business initiatives.

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Top 10 Reasons for FDA Warning Letters to Medical Device Firms

By Chris Celeste

The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.

The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.

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India’s Growing Cancer Market Offers Opportunities to Device Companies

By Ames Gross

As India’s cancer burden grows, the Indian cancer diagnostic and treatment market offers many opportunities for Western medical device companies that make such products. To succeed, Western companies need to develop their strategies in India carefully.

As India’s cancer burden grows, the Indian cancer diagnostic and treatment market offers many opportunities for Western medical device companies that make such products. To succeed, Western companies need to develop their strategies in India carefully.

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Interview: Device Design and Development in the New Environment

By Sangita Viswanathan

There is a pressure on medical device product development teams to come to terms with new types of users, environments, distribution and sales models as opposed to more traditional scenarios of device use and sale, says ide’s Richard Sokolov.

There is a pressure on medical device product development teams to come to terms with new types of users, environments, distribution and sales models as opposed to more traditional scenarios of device use and sale, says ide’s Richard Sokolov.

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