AGNOTEX has successfully provided high quality products and services to the medical market key rule players. possess the expertise to design, develop, validate, and manufacture Class I, II and III electronic medical devices. Whether you are looking for a complete turnkey solution, or just supplementing your internal capabilities, AGNOTEX has the background and flexibility to meet your requirements. AGNOTEX offers the opportunity to confidently outsource your project needs.
AGNOTEX utilizes the latest computer technology for all aspects of the organization from the Enterprise Resource Planning (ERP) software, to computer aided engineering tools.
Examples of Contract Manufactured Medical Devices
Dental Anesthesia Delivery Systems
Thermo Therapy Systems
Medical Anesthesia Delivery Systems
Electrical Teeth Whitening Systems
Endoscope Leak Detection Systems
Automated External Defibrillator (AED) Manufacturing Line
Intensive Care Ventilator (BIPAP, CPAP, EMERGENCY, CLINICAL, TRANSPORT, INFANT)
Resuscitation Ventilator (CPAP, INFANT)
Our electronic contract manufacturing capability is structured to produce/manufacture a wide variety of products for its customers. AGNOTEX can manufacture small quantities of prototypes and pre-production units to large quantities such as the 50,000+ unit/year.
Our experience with both Class I, II and III medical devices minimizes problems and facilitates quicker product turns. Changes or product updates are also streamlined due to AGNOTEX's in house engineering staff.
Class I medical manufacturing and medical device design
Class II medical manufacturing and medical device design
Class III medical manufacturing and medical device design
Electronic and electro-mechanical contract manufacturer
Assembly and precision hand or machine soldering of printed wiring boards
Thru Hole or SMT assembly
Complete panel and chassis wiring
Cable harness fabrication
Computer-based manufacturing control system (ERP)
Test: Qualification through burn-in
Full service device packaging
Device history record generation
Quality Assurance System:
+ Certified to ISO 9001:2008, AS9100C & ISO 13485:2003
+ Compliant to cGMP
+ Compliant to FDA Quality System Regulation (QSRs) 21 CFR 820
AGNOTEX’s Engineering Dept. provides outstanding capability not found in many small companies. From the design of simple fixtures to complete systems, the attention given to performance, reliability and quality does not vary.
Each engineer is proficient in both hardware and software design. This capability increases efficiency and reduces cost as the engineer who writes the operating software is intimate with the hardware he/she is trying to control.
As products become more sophisticated, medical device performance is highly dependent on reliable, verifiable and maintainable software. AGNOTEX has a history of providing embedded and PC based architectures for numerous product requirements. By utilizing current development tools, coupled to a controlled design structure, the customer is ensured product and regulatory specifications are satisfied.
In addition to having the latest design tools, AGNOTEX possess the staff and expertise to design and develop electronic systems that meet all domestic and international safety requirements (IEC 60601 or UL 2601 and CAN/CSA-C22.2 60601).
Engineering system certified to ISO 9001:2008 & AS9100C
Safety Requirements to IEC 60601 or UL 2601 and CAN/CSA-C22.2 60601
Software Verification and Validation
Product and Design Validation
Perform hardware/software tradeoffs in order to achieve desired goal at minimum cost.
Execute the electrical and mechanical designs needed for hardware fabrication.
Compose and debug all related software.
Breadboard and test various design approaches.
Layout, verify and tool required printed circuit boards.
Provide complete manufacturing documentation package.
Procure/Fabricate subassemblies and systems.
Assemble, test and debug subassemblies and systems.
Support Manual Publication, e.g., theory of operation and troubleshooting procedures.
Conduct qualification testing