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.
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.
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.
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.
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.
Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.
Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
With an aging population, technological innovations and more and more people needing medical devices for a sustained quality of life, the risk of long-term harm or damages increases when devices are not manufactured, imported or used properly.
With an aging population, technological innovations and more and more people needing medical devices for a sustained quality of life, the risk of long-term harm or damages increases when devices are not manufactured, imported or used properly.
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
