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Cognition Corporation has been offering solutions for product and process development for more than ten years. Cognition offers two core products: Cognition Cockpit™ and Enterprise Cost Management™ (ECM). Thousands of users worldwide have used Cockpit and ECM to manage their product development and to meet performance, cost, risk, and schedule targets.
The Cognition team is made up of engineers with experience in marketing, product development, Six Sigma, CAD/CAE, object-based data management, and the most advanced web development techniques. Many of our technical staff are black belts in Six Sigma and Design For Six Sigma (DFSS). All of our staff are trained to think and act with a total systems engineering approach to all projects, including the development of our own systems engineering software!
Our goal has always been to provide engineers with collaborative solutions to problems they face every day, without adding overhead and additional time burdens to already heavy demands. Our software should never "get in your way." We know we are successful when people think of our software as just a part of the way they do their job. Just like email and the internet, Cognition’s software is designed to make what you want and need to do easier.
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Acera Innovation is a software as a service software (SaaS) company with complimentary professional services. We are head-quartered in the heart of the Medical Device heartland in Plymouth, Minnesota. Acera brings over 50 years of combined experience and unique experience to solving the challenges medical device companies face in product development and regulatory compliance. Acera’s customers cover the spectrum, from startups with over 1 year ahead of them before getting to market to Class 1 companies just getting into the market to larger companies with hundreds of Class III products in market and facing upcoming audits.
Acera Innovation is proud to introduce Acera Pathway, the latest product offering is the first solution offering a collaborative, integrated solution for product development, project management and a quality management system, infused with medical device intelligence. Acera's SaaS based offering of Pathway enables your team to start collaborating today, no hardware to purchase, no software to install, no hosting provider to manage. Acera offers a pay-as-you-go, per subscriber, month to month model to fit the unique needs of the medical device startup.
Averion is an international CRO that specializes in medical device trial management and regulatory consulting. We have 26 years of experience and to date, have conducted over 140 medical device studies and helped clients gain PMA or HDE approval for 30 products. Every PMA application that has been accepted for filing has been subsequently approved. Collectively, we bring deep understanding of regulatory rules, CMS thinking, precedents, and division-specific concerns from a unified regulatory, reimbursement, clinical, and statistical perspective. We offer the highest level of credibility and success to your team. Our approval record highlights our critical thinking and agency respect.
Clinquest, Inc. is a local Healthcare Product Development Organization and Specialty Contract and Consulting Service Provider for medical device development, particularly those in the Class 2 and 3 categories. Clinquest’s specific strengths for medical devices in early stages of development are:
• Regulatory Consulting and Support
• Regulatory strategy
o Pre-IDE support
o IDE and PMA applications
o Support 510K applications
• FDA registration and US Agent
• Preclinical and Clinical Trials
o Preclinical testing strategy and project management
o Clinical trial design (IDE studies) and implementation
• Clinical trial implementation, monitoring and project management
• Data management and statistics
• Risk Management Plans (ISO 14971)
o Risk and hazard analysis
o Safety reporting
• Pharmacovigilance Services for Marketed Products
o For approved medical devices the following specific post-marketing services are also available:
• Surveillance and vigilance reporting
• MDR reports
• Consumer complaint tracking and reporting
With a European office, we can also provide consultants and services that can help our clients to comply with EU directives and CE Mark approval systems as well as establishing testing and quality control systems.
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Wind River, a wholly owned subsidiary of Intel Corporation (NASDAQ: INTC), is the global leader in Device Software Optimization (DSO). Wind River enables medical device companies to develop, run and manage device software faster, better, at lower cost and more reliably to accelerate your time-to-market for highly differentiated devices.
The world of medical electronics is shifting fundamentally. Equipment designs have traditionally lasted two decades, with years of heritage and testing behind each one. Now more innovation is demanded, with new features and new versions being developed much faster, based on digital systems. More focus is being put on cost-effective implementation so more units can be deployed across more hospitals and surgeries.
To develop this next generation of safety-critical medical devices, designers and system architects must consolidate hardware, reduce cost, and reduce time-to-market while never compromising their platform’s stability, safety, and security.
Wind River platforms are pre-integrated, fully standardized, enterprise-wide development solutions. They reduce effort, cost and risk and optimize quality and reliability at all phases of the device software development process, from concept to deployed product.
Wind River enables medical device manufacturers to leverage existing investments, focus resources on core competences as well as revenue components, and achieve efficiencies with our proven runtime platforms and standards-based tools. Customers can rely on Wind River’s world-class support and professional services to achieve project success.
Founded in 1981, Wind River is headquartered in Alameda, Calif., with operations worldwide. To learn more, visit Wind River at http://www.windriver.com/solutions/industrial/medical.html
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OrthoKinetic Technologies (OKT) is a biotechnology consulting firm to guide medical device companies in the orthopedic, neurosurgical, cardiovascular, and dental arenas towards the development of safe implants for clinical translation. OKT successfully guided multiple medical device companies towards the development, verification, and validation of safe and efficaceous medical devices that led to successful FDA clearances.
OrthoKinetic Testing Technologies (OKT2) was formed as a subsidiary to OKT in 2008 and is a full service medical device testing enterprise whose purpose is to conduct the testing, evaluation, and the implementation of the implant testing and assessment for FDA submissions. OKT and OKT2 can serve as the first choice and point of contact for medical device companies from the design stage through development, testing, and FDA submission. Furthermore, OKT serves as a liason for many device companies to the FDA, as well as for investors interested in funding novel technologies with innovative companies. The combination of OKT and OKT2 is truly a “one-stop shop” with 25+ years of experience and state-of-the-art equipment, technology, and techniques.
Plex Online on-demand ERP solution for the life sciences industry is a cost effective "software as a service" (SaaS). Plex Online offers over 350 functional modules, providing instant access to vital information using a simple web browser. The system features industry-leading materials and supplier traceability, quality solutions specific to the life sciences, and electronic signature capability. A full suite of Enterprise resource planning (ERP), customer relationship management (CRM); production scheduling and supply chain management (SCM) functions help medical device manufacturers meet Quality System (QS) regulations under section 520 of the Food, Drug and Cosmetic (FD&C) Act.
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4DDynamics is a European based company specialized in providing software & hardware solutions based on structured light technology. With more than 10 years of experience in the scanning industry; 4ddynamics currently is releasing several specialized scanning solutions. Within the Medical industry the SLI® scanners are being used for surface scanning of; for example Face masks, a patient Back, Breasts for reconstruction or plastic surgery. Also hands and skin is being scanned by dermatologist. The 4DDynamics SLI® scanner is also used for prosthetic arm and legs where there is an accurate reconstruction possible and therefore a perfect fit of the prosthesis.
Further not only the 4DDynamics SLI scanner is being used for preservation of medical specimen’s in full HD surface and texture. Also our proprietary software is being used for the reconstruction of the specimen’s, these could be dried specimens, wax specimen’s or even parts held ( some for up to 300 years) within Formaldehyde in glass containers. All of these are carefully scanned (without deterioration of the specimen’s, and accurately reconstructed). This data is than being used for medical training, teaching and documentation of rare deceases in a worldwide accessible database.
This is a unique project, which requests unique technical solutions, and could be widely used for other specimen collections worldwide. 4DDynamics is currently seeking partners in order to expand worldwide.
Almac Clinical Services is a long established and trusted company offering a full range of clinical supply solutions that provide genuine improvements to the supply chain. Our core services for medical devices include supply blinding, packaging and distribution via a global depot network.
• Comparator sourcing
• Over-encapsulation
• Primary & Secondary Packaging
• Label Printing
• Labelling of clinical supplies
• Analytical Services
• Global distribution (+2-8C/frozen/controlled)
• Global Depot network
• Shipping Temperature Electronic Monitoring System – STEMS
• Label Approval System - LAS
Identification Products, was founded in 1968 and has adapted consistently to advancing technologies. While much has changed in the 30 plus years since their beginning, two things have remained constant: dedication to their customers and their high standards for quality products. Id products has two locations in Bridgeport, Connecticut. Both of these production facilities have state-of-the-art equipment, that enables Identification Products to be your complete source for prepress engineering through printing and fabrication.
Our product listing is wide-ranging. Each front panel overlay, custom label, as well as our entire product line is manufactured with precision quality. Our commitment to quality, on time delivery and extreme customer service makes us the leader in our industry. We offer a complete set of high performance and cost effective materials and adhesives. We ask all the pertinent application questions upfront to ensure that the best possible materials and methods are used for your product. Collaborate with our sales engineers, designers and knowledgeable customer service personnel to select the right combination for your application.
Remember, our product capabilities are continually increasing. Be sure to check out what’s new at id www.idproducts.com to see our new products and applications.
Our Products:
Precision Graphic Overlays
Custom Labels
Nameplates
Gaskets/Insulators
EMI/RFI Shielding
Barcodes
Custom Panels
Polyurethane Doming
Additional Products
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