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Qualcon's Medical Device Development including:
Qualcon’s product development
team works with clients to take "medical device ideas" from
the initial concept phase through delivery to your customers, while
maintaining the necessary FDA standards, certified testing, validation
requirements and documentation. Qualcon’s capabilities include:
Design Assistance
 | Medical Devices Designed for FDA: Class I, II, and III |
| New Product Development |
| Prototyping |
| Therapeutic Device Development |
| Gas
Delivery System Development |
| Catheter
Development |
| Biomedical Monitoring Device Development |
| Drug Delivery System Development |
| Pharmaceutical Device Development |
| Combination Product Development |
| Clinical Feasibility Studies |
| Therapeutic
Ultrasound Device Development |
| Invasive
Therapeutic Ultrasound Devices |
| Non-Invasive
Therapeutic Ultrasound |
| Phototherapy Devices |
| Dose Counters for MDI Devices |
| Shake/
Fire System for MDIs and NSP |
| Evaluation of Human Factors Design |
| RoHS Compliance Analysis Services for
Medical Devices |
| System Verification and Validation |
Software Development
| Full Software Development |
| Embedded Systems |
| Wireless Systems |
| High Level Assembly Languages |
| GUI User Interfaces |
| Motion Control |
| Real Time Systems |
| Embedded Linux Systems |
| Embedded Windows Systems |
| LABVIEW Programming |
| Multi-tasking control |
| Microprocessor Programming |
| Software Verification and Validation |
Documentation Assistance
| Technical Dossier needed to obtain FDA 510K, PMA or IND submission
package. |
| System Requirement Documents |
| System Specifications Documents |
| Study Report Generation |
| Test Protocols and Test Reports |
| FMEA (Failure Mode Effects Analysis) |
| System Verification and Validation Documents |
| Quality and Regulatory Controls |
| Device History Files |
| Documentation Control |
Product Testing Assistance
| Certified Testing to Meet ISO, CE, FDA, UL Requirements |
Animal Studies and Clinical Trials
| Assistance in setting up Animal Studies |
| Clinical Trials Support |
| System Training |
| Service Center for Device During Clinical Trials (ie. System
calibrations and maintenance). |
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 world-class
design-for-manufacturability (DFM) consultation; material
specification, procurement and management; printed circuit board
assembly (capacity of 1.2 million component placements per day);
manual and automated (20-seat line) box-build assembly; test and
packaging. |
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. |
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