Medical Device Link.

PRODUCT UPDATE

Dassault Systèmes

Designers of surgical equipment can use finite-element analysis software to create a realistic simulation of products, materials and processes behaviours. The Abaqus 6.8-EF from Dassault Systèmes (Velizy-Villacoublay, France; www.3ds.com) includes a general contact implementation that offers an automated method for defining contact interactions. It can simulate the contact between different components in an assembly as well as interactions with surrounding tissue. The software also includes a low-density foam model for medical packaging.

The company’s SolidWorks software is a product design platform serving the mechanical design community in a broad range of industries including medical device manufacturing. The SolidWorks line of products combines ease of use with advanced 2-D and 3-D design tools.

In addition to raw out-of-the-box performance improvements, SolidWorks 2009 introduces SpeedPak, a new approach to large assembly handling. The new feature reduces the amount of computer memory needed while maintaining full graphic detail and associativity. As a result, design engineers can build and work with massive assemblies and drawings using a high-performance system with memory efficiency.

MasterControl Inc.

A provider of document, audit and quality management software, MasterControl Inc. (Salt Lake City, UT, USA; www.mastercontrol.com) has introduced an updated version of its flagship software. Known as MasterControl Version 8.0, the software introduces a variety of functional enhancements to the firm’s existing products.

Among the products available as part of Version 8.0 of the software platform is MasterControl Supplier, which was developed to enable companies to efficiently manage and approve vendor lists and to track supplier quality and supplier status. The software automatically tracks and stores supplier status and quality information in a single, easy-to-access location.

Goods or services can be added to the approved-to-supply list by linking them to a specific supplier in MasterControl. Suppliers, conversely, can be added the same way. If a part is linked to a supplier that is not approved, the link is disabled until the supplier becomes approved or is reapproved.

MasterControl QMS CAPA solutions are three distinct programs designed to automate and manage the Corrective and Preventive Action (CAPA) process and integrate it with other quality processes such as change control, audits, training, nonconformance resolution and customer complaints. The intelligent MasterControl QMS CAPA system guides users through the CAPA process with the assistance of embedded decision mechanisms. The product is offered with best-practices training, services and consulting.

Elysium Inc.

Support software can remaster design features from one computer-aided design (CAD) system to another, minimising translation and repair times. CADfeature 8.2.1 from Elysium Inc. (Southfield, MI, USA; www.elysiuminc.com) offers a 2-D drawing translation function that supports view associativity with the target 3-D model. It also has a tool that translates existing metadata for CAD files.

The software includes diagnostic capabilities that check source and target files to ensure that translation has been accurate. In the case of discrepancies, the software alerts users and enables them to remaster affected files manually.

Kistler Instrumente AG

Software from Kistler Instrumente AG (Winterthur, Switzerland; www.kistler.com) is dedicated to analysis of the injection moulding process. It yields information about the effects of a variety of parameters and unlocks the potential for optimising mould quality and cost-effectiveness. Database- and web-based software CoMo MIS Type 2829A stores, visualises and analyses process data acquired by the CoMo Injection system monitoring Type 2869B during injection moulding. A browser is used to retrieve from the database information about all of the current and completed production runs and batches.

The “Curve Viewer” module allows quick access to the curves of all saved cycles. The monitoring functions and their results can be displayed at the same time. Flexible superimposition functions allow easy analysis of changes in the process over a freely selectable number of cycles or time period. The Data Export function supports simple exporting of data to programs such as Excel or statistical tools. Batch data can be opened directly in an included statistical program.

Blue Mountain Quality Resources

Software developer Blue Mountain Quality Resources (State College, PA, USA; www.coolblue.com) has announced a new release of its regulatory asset manager software. The comprehensive browser-based application is designed to harmonise maintenance, calibration and validation. The release introduces a variety of functions that are designed to be of value to quality organisations, asset end-users and engineering management.

New process, lot and test management functionality within the Blue Mountain Regulatory Asset Manager reportedly allows companies to gain more control over manufacturing and quality control processes. In addition, it enables companies to quickly discover the impact of out-of-specification assets on production and other operations. The software enables organisations to determine where assets were used within production batches or assay tests, enabling them to take quick and effective action to remedy issues that may arise. This functionality reportedly is faster and produces more-complete results than traditional impact assessments with data mining from paper batch records and test methods, where inadvertent omission of processes affected by an anomalous asset may be a concern.