Compliance Management for Medical Devices
How can medical device companies establish end-to-end regulatory compliance as a strategic initiative?
How can medical device companies establish end-to-end regulatory compliance as a strategic initiative?
It’s Not About Faster Approvals, but About Better Availability, says FDA Commissioner Hamburg
Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.
Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.
When Heart Valves Come from a Printer
As wearables for smart monitoring require efficient components, it is estimated that 67 percent more 3D printers will be sold this year, than in the previous year, and the medical field is an area of application with great potential.
As wearables for smart monitoring require efficient components, it is estimated that 67 percent more 3D printers will be sold this year, than in the previous year, and the medical field is an area of application with great potential.
What Changes Should Manufacturers Expect From FDA?
With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.
With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.
Medical Device Companies Look East
China’s rapidly expanding cancer market provides many opportunities for Western medical device companies.
Fine Laser Cutting for Medical Components
Fine thin metal laser cutting is an ideal technology for the specialized cutting requirements found in the manufacturing of medical tube tools and components, which require an array of cut features with sharp edges, contours, and patterns within edges. From surgical instruments used in cutting and biopsy, to needles containing unusual tips and side wall openings, to puzzle chain linkages for flexible endoscopes, laser cutting provides higher precision, quality, and speed than traditionally used cutting t…
Fine thin metal laser cutting is an ideal technology for the specialized cutting requirements found in the manufacturing of medical tube tools and components, which require an array of cut features with sharp edges, contours, and patterns within edges. From surgical instruments used in cutting and biopsy, to needles containing unusual tips and side wall openings, to puzzle chain linkages for flexible endoscopes, laser cutting provides higher precision, quality, and speed than traditionally used cutting t…
What Can Apps Do For Health?
Apps are being successfully used in the field of individual, community-related and company prevention – even if is only to help employees leading healthy lives for example. But which apps are actually worth recommending in the field of health? How good are these apps and what constitutes a good app?
Apps are being successfully used in the field of individual, community-related and company prevention – even if is only to help employees leading healthy lives for example. But which apps are actually worth recommending in the field of health? How good are these apps and what constitutes a good app?
What are the 4 Key Elements in Compliance Management Software?
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?
Are you Ready for a Notified Body Unannounced Audit?
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.
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.
