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  • Orr on Engineering: Practical Realities in Product Design
    Orr on engineering: Prose of documentation, passion of design The engineering cycle roughly consists of requirements capture, conceptual design, detailed design, prototyping and refinement, design approval, production- process design, production, and deployment and support. This linear list is neat
  • Quality by Design in the Design Space
    . Monitoring the parameters of drug attributes results to less process and ultimately, less product variability. The advantage of the design space is it provides a wider range within which material attributes can vary in the future without supplemental FDA approval, said Chen. QbD also helps make
  • Seals of Approval
    share of design challenges opportunities, Coyle calls them particularly regarding the customization of the filling equipment to meet the needs of product and process. Foremost among these challenges was devising a means to ensure that particles of budesonide, Pulmicort s active ingredient
  • Regulatory Approvals for Planar Displays - AN111
    Planar Systems, Inc. has sought compliance certification from several regulatory agencies for Planar displays. These certifications will ease the design process by supplying our customers with agency-recognized components when possible. Standards such as IEC 601.1 are system-level device
  • Part and Mold Design (.pdf)
    equipment. These factors, coupled with other design concerns - such as agency approval, processing parameters, and part consolidation - are discussed in this chapter
  • Rapid Prototyping Accelerates The Design Process
    techniques in the final stages of product development and the transition to manufacturing. But the greatest potential for 3D modeling lies earlier in the design process where superior designs are conceived and the roots of development delays are put down. Properly used, rapid prototyping can
  • Transformers supplier -FDA Section 510 (k) Approval
    Medical Original Equipment Manufacturers (OEMs) are required to. submit an FDA Section 510 (k) application when they plan to market. a new equipment design. Section 510 (k) of the U.S. Food, Drug and. Cosmetic Act allows the FDA to determine whether the device is. equivalent to similar equipment
  • Medical Device Link . Design considerations for IVD clinical trials:
    Cheryl L. Hayden and Michael L. Feldstein An IVD clinical trial represents a major investment for the sponsoring company; consequently, it is important to maximize the utility of the trial. One way to accomplish this is to design the trial protocol to include several time-staggered end points
  • Medical Device Link . An Update on EMC Compliance Issues Manufacturers should take note of recent developments in the EMC regulatory arena to ensure that their devices make it through the approval process.
    Recent reports of medical device malfunctions caused by interference from licensed radio-frequency sources have underscored the importance of ensuring electromagnetic compatibility (EMC) in the design, production, and use of electronic medical apparatus. FDA issued a public health advisory
  • Medical Device Link . Simplifying Medical System Design with PC/104 Modules
    and efficiently guided through a maze of complex and time-consuming FDA approvals. How can designers take maximum advantage of advances in technology, yet bring new products to market in a timely manner and within budget constraints? One solution is to cleverly combine product-specific proprietary hardware

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