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- Myths and realities in medical packaging: this round-up of packaging myths provides a reality check on the real world of packaging medical products. Table I shows medical device FDA-assisted recalls due to packaging failures. (design).
- Myth: We will select the package just before we introduce the product. It will be fine. Reality: The package is an integral part of the product, especially for products that will be sterilised. The package protects and cushions the product, c...
- Research articles 2003-03-01
- New Product Strategy and Partnership/Acquisition Focus for Medical Products Company
- This $200 million disposable medical device division of an international medical products company faced maturity in its present markets and limited R&D funds to allocate to next-generation products. PRTM was hired to implement an actionable product strategy so the company could realize its dreams of being a major player in...
- Case studies
- RFI integrates wireless technology into medical devices.(Testing)
- RFI Global Services Ltd has nearly 20 years' experience in the medical product approvals market, working with its customers to meet the regulatory, EMC and wireless requirements for their products. It specialises in wireless ... RFI Global Services Ltd has nearly 20 years' experience...
- Research articles 2006-01-01
Additional Resources
- Streamlining Quality Assurance and FDA Compliance in the Medical Device Industry: From Innovation to Execution
- Innovation has always have been the lifeblood of medical device companies as they strive to deliver new products that improve patient outcomes and enable the medical community to deliver the best possible patient care. Today, however, innovation alone cannot sustain medical device companies. Medical device manufacturers must execute flawlessly by...
- White papers 2003-11-19
- PTC Introduces PLM Solution for the Medical Device Industry; Windchill Medical Device Template Enhances FDA Regulatory Compliance Capabilities
- NEEDHAM, Mass. -- PTC (Nasdaq: PMTC), the Product Development CompanyTM, today announced the general availability of the PTC Medical Device Template, combining leading, industry specific capability and consulting expertise. Built on top of WindchillR PDMLinkTM, this packaged services offering, meets the unique needs of the medical device and equipment industry...
- Research articles 2005-03-01
- Winston-Salem, N.C.-Based Medical Device Company's Product Hits Grocery Stores.
- By Kristi E. Swartz, Winston-Salem Journal, N.C. Knight Ridder/Tribune Business News Sep. 27--ALR Technologies Inc., a medical-device company based in Winston-Salem's downtown research park, began selling its first product in some Triad grocery stores this week. The tiny, electronic ALRT...
- Research articles 2002-09-27
- Helix Medical--silicone medical device and component technology.(Product Literature Advertising Section)
- Helix Medical develops, manufactures and supplies custom fabricated silicone components and products for the medical device industry world-wide. Manufacturing capabilities include: * Compression/transfer molding * Liquid Injection Molding * Extrusions...
- Research articles 2005-01-01
- Two cost-effective solutions from Dow Corning for medical device fabrication and pharmaceutical processing: Dow Corning® brand Class VI Elastomers and Dow Corning® brand Pharma Tubing
- The health care industry is rapidly changing, and consistent quality, product traceability and cost control are more important now than ever. Dow Corning, the global leader in silicone technology, offers two newly-expanded product lines to meet your needs in this dynamic environment: * Dow Corning[R] Class...
- Research articles 2003-10-01
- Increasing Medical Product Value With Early Evaluation of System Architecture
- Medical device and medical information management system companies are faced with ever-increasing pressure to get new products to market faster while continuing to comply with the Quality System Regulation and Design Control requirements. This paper discusses the importance of evaluating system architectures at the earliest stage of system definition, using...
- White papers 2004-05-25
- SAS Strategy for Corrective Action (CAPA): Solving and Preventing Product Nonconformities for Medical Device and Pharmaceutical Manufacturers
- Corrective Action - Preventive Action CAPA refers to a long-accepted, but often forgotten, quality practice for solving and preventing product nonconformities. This white paper discusses ways that SAS Process Intelligence supports and enhances any CAPA program. The paper begins with a brief discussion of SAS' commitment to quality processes. It...
- White papers 2003-11-24
- Physician Suits Against Pharmaceutical And Medical Device Manufacturers: Friend Turned Foe?
- This paper discusses that pharmaceutical and medical device manufacturers are all too familiar with the regulatory risks and with the potential for product liability claims from patients whenever a product is manufactured and sold. The Food and Drug Administration FDA has sweeping powers to regulate manufacturers before and after a...
- White papers 2003-01-01
- Quality System Development in Medical Device Start-Ups
- The medical device industry, with its broad spectrum of product technologies and medical applications, is characterized by innovation from small, often start-up, and companies. Medical device start-ups are challenged by limited resources, yet they must develop their technology, product and business strategy and simultaneously develop a quality system that is...
- White papers 2004-07-26
- MES reduces FDA compliance costs: medical device manufacturers face stringent regulations. Manufacturing Execution Systems can help reduce the cost of compliance.(Quality Software & Analysis )(Food and Drug Administration)
- Medical device manufacturers, like manufacturers in other industries, must control costs, ensure product quality and shorten time-to-market. For the life science manufacturing industry, a noncompliant product or process does not simply result in expe Medical device manufacturers, like manufacturers in other industries, must control costs,...
- Research articles 2004-02-01
- Medical device sector's new frontier is automated quote and contract generation.
- By Staff One consequence of medical-device market growth is that manufacturers may find themselves needing a customer relationship management CRM solution, says Ehab Samy, senior product manager at Pivotal , the CRM division of CDC Softw ...
- Research articles 2007-01-01
- Medical device packaging.(Bomarko Medical Packaging)(Brief Article)
- The co. has announced its plans to enter the medical device packaging market, extending its converting and product development capabilities into sterilizable packaging for medical device manufacturers, hospitals and other healthcare facilities. The co., a supplier to the finger bandage and personal product markets, will supply...
- Research articles 2001-09-01
- The future is here: electronic medical device reporting
- Medical device manufacturers are required--through FDA 21 CFR Part 803--to submit medical device reports also called MedWatch reports when their devices are involved in patient safety issues or product malfunctions. The FDA receives more than 300,000 of these reports annually, and all of them used to be entered manually into...
- Research articles 2008-03-01
- ENOVIA MatrixOne Introduces Enhanced PLM Solution for the Medical Device Industry; PLM Accelerator Drives Profitability, Collaboration and Compliance at Each Stage of the Product Lifecycle
- WESTFORD, Mass. -- Dassault Systemes DS (NASDAQ: DASTY; Euronext Paris: #13065, DSY.PA), a world leader in 3D and Product Lifecycle Management PLM solutions, today announced the latest updates to the MatrixOne Medical Device Accelerator MDA. The MatrixOne MDA manages Quality System Regulation QSR/ISO-regulated design processes, projects, documents and data, and...
- Research articles 2006-07-10
- Speed testing: rapid injection-molding helps gain quicker approvals for medical equipment designs.(Medical Design)
- Medical device manufacturers often face laborious testing cycles that involve rigorous product evaluations to bring products to market or to submit them for clinical trials. With so much time spent during the testing and certification processes, th Medical device manufacturers often face laborious testing...
- Research articles 2007-01-01
- St. Francis Medical Technologies to Present at the Medtech Insight and Windhover Information's ''In3 Medical Device Summit'' Conference, June 21-23, 2006 in San Francisco, CA
- SAN FRANCISCO -- St. Francis Medical Technologies, Inc.R announced today that it will present on Thursday, June 22 at 11:40am at the Medtech Insight and Windhover Information's "In3 Medical Device Summit" Conference, at the Palace Hotel in San Francisco. Chief Financial Officer Michael Bates will be presenting an overview of...
- Research articles 2006-06-09
- Premier Research Group Earns ISO 13485 Certification for Medical Device Operations
- LONDON -- Premier Research Group Limited, the international pharmaceutical services company, announces that its subsidiary, Premier Research Group SA, has earned ISO 13485:2003 certification in support of its global medical device operations. ISO 13485:2003 is a stringent, globally-recognized standard for management systems for medical device manufacturers and service providers....
- Research articles 2008-07-01
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