German
“Manufacturers are providing strong support for the EPRD”
18.07.2011
The new endoprosthesis register aims to catch “outliers” in the field of endoprosthetic care at an early stage, achieving greater transparency and quality in the treatment of arthropathy sufferers. Professor Joachim Hassenpflug explains how the register is structured and the benefits of an interdisciplinary database. [more...]
EPRD: Putting an end to quality problems with implants?
18.07.2011
Artificial hip or knee joints can prove to be veritable time bombs for patients. Particularly if sloppy work during manufacturing, material defects or dilettante surgeons are involved. The results are new operations with all the ensuing risks. A Germany-wide endoprosthesis register (EPRD) has now been established to put an end to the bungling with defective or incorrectly implanted endoprostheses. [more...]
Medical Device Authorisation: Clear or Cloudy?
17.05.2011
According to a comparison study conducted by the Boston Consulting Group, the market authorisation of medical innovations proceeds at a more rapid pace in the EU than in the US. In spite of this, the comparison did not show an increase in recalls. Summary: The faster market access did not come at the cost of patient safety. Does this mean that all is well in the world of medical device authorisations in the EU? meditec writer Ramona Riesterer portrays the thoroughly mixed opinions in the medical technology industry. [more...]
Outsourcing – yes or no?
17.05.2011
Outsourcing business areas is gaining increasing importance: The scope of outsourcing is expanding to the tune of ten to 15 percent annually worldwide. By 2013, the volume is expected to reach $ 230 billion. The trend spilled over into the medical technology industry for some time now. After all, outsourcing will provide a given medical technology OEM with the opportunity to create flexible and lean structures that permit the company to concentrate on its core business. In the medical technology sector, outsourcing concerns mainly administrative know-how. [more...]
Engineering: Ready for the market faster with partners
17.05.2011
Engineering service providers which provide their clients with support during the product development phase have also established themselves in the medical engineering segment. This often has to do not only with action research, design and the creation of drawings, but also with special competencies, e.g. in ergonomics, and the assessment of the usability of medical products. [more...]
Potential savings for diagnostic laboratories
15.03.2010
Many processes in in-vitro diagnostics can be automated without jeopardizing the quality of the results or decreasing the medical significance of the tests. Process automation holds competitive significance in high workload laboratories. [more...]
Clearing legal hurdles with confidence
15.03.2010
The 4th amendment of the Medical Devices Directive (MDD), effective as of 21.03.2010, will have a considerable impact: in future, for example, dedicated software which performs defined relevant medical functions will in future be counted as an active medical device. And operators will be subject to more stringent regulations with regard to in-house products: wherever networked medical systems are created, these can be defined as medical devices according to the 4th MDD amendment. [more...]
Manufacturing technology accelerates medical technology
15.03.2010
Manufacturers of machine tools, control systems and machining tools are advancing medical technology. Example: a complete knee implant made of a cobalt-chromium alloy that is extremely difficult to machine can be milled in less than 30 minutes. The MEDTEC Europe trade fair in Stuttgart from 23 to 25 March 2010 will show exactly how medical technology can profit from modern manufacturing. [more...]
Manufacturing outsourcing: The best kept secret?
15.03.2010
In today’s medtec companies the „manufacturing outsourcing” folder is kept under lock and key. And no wonder – double digit cost savings are well documented. And more than ever before, the right definition of a company’s own core competencies will determine the competitive ability. [more...]
Microsystems conquer medical technology
25.02.2010
From a miniaturised measurement laboratory to a biomechanically-controlled leg prosthesis – manufacturers of integrated microsystems long ago discovered the field of medical devices and applications. Throughout Europe, the hunt is already well underway for promising solutions. [more...]
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