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Feature Articles
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Validation and Six Sigma
Medical device design and manufacturing organisations, and their suppliers, that are pursuing operational excellence are urged to employ Six Sigma. It is a validation activity that addresses risk and by harnessing this methodology companies can accelerate and improve their risk management.
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Outsourcing For Product Success
and Restful Nights
The potential benefits of outsourcing are well known, but the decision to contract with subcontract partner can be daunting. This article examines how to determine if a product is suitable for outsourcing and the steps to take to identify and qualify the correct outsourcing company.
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Micro Machining Brain Implant
Needle Arrays
A major challenge in the industry is the creation of a degree of control over electromechanical prostheses in severely disabled spinal injury patients or loss-of-limb patients. The case study described here illustrates the use of microelectrodischarge machining, which is a critical component in the creation of an engineering system that interlinks directly with the brain.
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The Challenges of Packaging
Combination Devices
This article focuses on the development of a packaging format for drug eluting stents where the package not only has to meet the needs of the stent, but also the needs of the drug incorporated into its polymer coating. The package has to allow the transfer of ethylene oxide gas for sterilisation, but when in storage, must provide a barrier to keep out moisture and oxygen.
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Aziz Joins ARV Excellence in Europe
ARV Excellence Ltd has appointed Dr. Kaiser Aziz as senior regulatory, clinical, and quality affairs consultant. Aziz brings a wealth of experience to the company after serving 29 years with the FDA in a number of senior roles. Throughout his career, Aziz worked with individual and industry organizations in design and total product life cycle (TPLC) approaches to premarket applications for medical devices, pharmaceuticals, and combination products. |
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AWS Group Appoints Weston as Non-Executive Chairman
AWS Group, an independent Electronic Manufacturing Solutions (EMS) provider, has announced the appointment of former British Aerospace chief executive, John Weston, to its board of directors as non-executive Chairman. Starting as an undergraduate apprentice with the British Aircraft Corporation in 1970, Weston rose to become Chief Executive of British Aerospace in 1998. |
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