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Qualcon's Medical Device Service Offering (FDA Class I, II, and III):

bulletBusiness Plan
bulletDesign
bulletDevelopment
bulletCompliance
bulletTesting
bulletManufacturing
bulletFulfillment Process

Qualcon’s unsurpassed capabilities enable it to transform your idea into a tangible FDA-approved product. No other fulfillment partner in the U.S. offers Qualcon’s "one-stop-shop" features for high-mix / low-volume medical device markets.

Business Plan

bulletQualcon can assist its customers in completing a business plan, including a business description, market analysis, customer identification and financial pro-formas. Other consultation available includes pre-post market insurance reimbursement planning, product distribution, national contract negotiations (GPO & IHN), marketing collateral development and tradeshow selection.

Design

bulletQualcon offers the experience and talents of more than 30 hardware and software design engineers with expertise in plastics, metals, mechanics, interconnects, electronics, and ergonomics.

Development

bulletQualcon provides complete prototyping services, including electronic printed circuit board assembly, custom plastics and metals, as well as rapid SLA models.

Compliance

Qualcon’s FDA 510(k) consultation services include:

bulletDetermine all 510(k) requirements (or exemption).
bulletIdentify a predicate device(s) or verify that the predicate device(s) offered in the submission meets FDA criteria.
bulletWrite the "substantial equivalence" section of the 510(k) that compares the device to the predicate device(s).
bulletDetermine if FDA Guidance Documents are applicable to the proposed device.
bulletContact the FDA Office of Device Evaluation to determine any special requirements for its review of the device.
bulletPrepare and submit the FDA 510(k) application to the FDA in electronic and hard copy format.
bulletWrite the Executive Summary section of the 510(k).
bulletCoordinate with Qualcon’s customer and the FDA reviewer, and assist with the preparation of a response if the FDA has questions or requires additional information.
bulletMonitor the progress of the FDA 510(k) Pre Market Notification through the FDA review process and provide periodic updates.
bulletQualcon also addresses regulatory compliance (pre- and post-market) in Canada, the EU, Asia and other international markets.
bulletQualcon offers complete FDA cGMP (Current Good Manufacturing Practices) consultation and/or compliance.

Testing

bulletQualcon can develop and implement all device testing required to meet CE, ETL, FDA, ISO and UL requirements.

Manufacturing

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Qualcon is registered to standards of ISO 9001:2000 and ANSI/ESD-S20.20-1999; and specifically certified to the stringent medical device manufacturing standards of US FDA cGMP and ISO 13485:2003.

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Qualcon’s manufacturing services include design-for-manufacturability (DFM) consultation; materials specification, procurement and management.

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Qualcon offers world-class custom electronic printed circuit board assembly services (1.2 million components placed daily).

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Custom plastics and metals capabilities provided by Qualcon include custom plastics mold design and build, custom plastics insert and injection molding, liquid silicone rubber (LSR) molding, pad printing, thermoforming, ultrasonic welding, CO2 laser marking, hot stamping, automated precision needle grinding and wire & cable processing (cable assemblies).

bulletQualcon offers final assembly services via cellular workstations and a state-of-the-art automated (20-seat line) box-build line.
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FDA-certified ETO sterilization and clean room services are available.

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Qualcon provides complete in-circuit and functional test services, as well as environmental test and burn-in services.

Fulfillment Logistics

bullet Qualcon’s FDA cGMP and ISO 13485:2003 registrations enable it to build and ship FDA-approved medical devices directly to its customer’s customers worldwide. Qualcon’s close proximity to Atlanta’s Hartsfield-Jackson International Airport provides the unique capability of shipping worldwide --- for next day delivery.
bullet Qualcon’s FDA cGMP and ISO 13485:2003 registrations enable it to serve as the international warranty/repair depot for its customer’s products.
bullet Qualcon provides international installation, on-site service and 24x7x365 call center support.

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Last modified: January 08, 2009