EU Notified Body Unannounced Audits and Your Suppliers

By Richard Vincins

The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.

The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.

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Ten Tips For Making the Right Connections

By David Cianciolo

From contacts and sealing, to cable assembly requirements and miniaturization, here’s a step-by-step guide for engineers to help them ask the right questions as they determine connectors they will be need for their devices.

From contacts and sealing, to cable assembly requirements and miniaturization, here’s a step-by-step guide for engineers to help them ask the right questions as they determine connectors they will be need for their devices.

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Engage Early to Get Product to Market on Time

This case study describes how Bioness, which develops products to help individuals around the world with neurological impairments regain their independence, D&K Engineering, a global product realization company, and UL Engineering collaborate to develop, manufacture and bring to market the Vector Elite – 2014 Medical Design Excellence Award Gold winner in the Rehabilitation and Assistive Device category.

This case study describes how Bioness, which develops products to help individuals around the world with neurological impairments regain their independence, D&K Engineering, a global product realization company, and UL Engineering collaborate to develop, manufacture and bring to market the Vector Elite – 2014 Medical Design Excellence Award Gold winner in the Rehabilitation and Assistive Device category.

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Medical Device Joint Ventures and Acquisitions in Asia

By Ames Gross

Acquisitions and joint ventures with Asian medical companies can provide many advantages for Western firms looking to grow their businesses in Asian medical device markets.

Acquisitions and joint ventures with Asian medical companies can provide many advantages for Western firms looking to grow their businesses in Asian medical device markets.

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Using Root Cause Analysis for Powerful Defect Prevention

Many product development teams use root cause analysis and root cause corrective action to identify the origin of defects in their development processes and prevent them from recurring. Though these can be complicated and time-consuming, automated product development solutions can help reduce the time spent on RCA, RCCA, code reviews, and other quality improvement efforts.

Many product development teams use root cause analysis and root cause corrective action to identify the origin of defects in their development processes and prevent them from recurring. Though these can be complicated and time-consuming, automated product development solutions can help reduce the time spent on RCA, RCCA, code reviews, and other quality improvement efforts.

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Biological Evaluation of Medical Devices

By Jan Peeters, Paul Malinovski

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

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New Japan Medical Device Regulations

By Ames Gross

The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.

The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.

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