|
| |
Qualcon's Medical Device Service Offering (FDA Class
I, II, and III):
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
 | Qualcon 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
| Qualcon 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
| Qualcon 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:
| Determine all 510(k) requirements (or
exemption). |
| Identify a predicate device(s) or verify that
the predicate device(s) offered in the submission meets FDA
criteria. |
| Write the "substantial equivalence"
section of the 510(k) that compares the device to the predicate
device(s). |
| Determine if FDA Guidance Documents are
applicable to the proposed device. |
| Contact the FDA Office of Device Evaluation to
determine any special requirements for its review of the device. |
| Prepare and submit the FDA 510(k) application
to the FDA in electronic and hard copy format. |
| Write the Executive Summary section of the
510(k). |
| Coordinate 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. |
| Monitor the progress of the FDA 510(k) Pre
Market Notification through the FDA review process and provide
periodic updates. |
| Qualcon also addresses regulatory compliance
(pre- and post-market) in Canada, the EU, Asia and other
international markets. |
| Qualcon offers complete FDA cGMP (Current Good
Manufacturing Practices) consultation and/or compliance. |
Testing
| Qualcon can develop and implement all device
testing required to meet CE, ETL, FDA, ISO and UL requirements. |
Manufacturing
|
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. |
|
Qualcon’s manufacturing
services include design-for-manufacturability (DFM) consultation;
materials specification, procurement and management. |
|
Qualcon offers world-class
custom electronic printed circuit board assembly services (1.2
million components placed daily). |
|
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). |
| Qualcon offers final assembly services via
cellular workstations and a state-of-the-art automated (20-seat
line) box-build line. |
|
FDA-certified ETO
sterilization and clean room services are available. |
|
Qualcon provides complete
in-circuit and functional test services, as well as environmental
test and burn-in services. |
Fulfillment Logistics
|
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.
|
|
Qualcon’s FDA cGMP and ISO 13485:2003 registrations enable it to
serve as the international warranty/repair depot for its customer’s
products.
|
|
Qualcon provides international installation,
on-site service and 24x7x365 call center support.
|
|
|
