European Medical Device Technology, September 2010, Volume 1, No. 7
September 1st, 2010
This Issue's Articles
Determining the appropriate classification of a medical device is critically important. All manufacturers marketing devices in Europe should refer to a newly updated European guidance document on device classification.
Designing a leak-testing system that meets appropriate reliability and reproducibility standards requires a thorough understanding of relevant test methods and technologies. That knowledge base is rarely available in house.
Acoustic micro imaging technology can identify latent defects in products during development and manufacture and prevent field failures.
ISO 11607 offers three possible routes to transit simulation of single-use products. While all three methods are equally valid, the schedules differ in detail and quantity.
The requirement for full compliance with ISO 11137: 2006 has not been welcomed by some members of industry because of associated expenses. In fact, increased auditing should lead to quality improvements and cost reductions.
Burdensome regulations and an atavistic aversion to risk are partly responsible for the relative decline of Japan’s medtech industry.
Lightweight yet resistant, composites can be a competitive alternative to metals and alloys for the fabrication of devices.
Ireland continues to be well positioned to take advantage of global trends in the life science sector, according to a recent report.
The global orthopaedic market is valued at approximately US$29 billion. Under the influence of orthobiology and nanotechnology, there is scope for significant growth, as long as there are sufficient practitioners to perform the procedures.
To optimise industrial cleaning techniques for orthopaedic products, manufacturers need to consider the material that is being processed, part geometry and a host of other factors.
Knowledge of material properties, machining expertise and robust quality systems are the hallmarks of a well-rounded supplier of metal fabrication services.
In good times and bad, the medtech outsourcing boom continues unabated. But the buyer still needs to beware.
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