Need Help with Developing Your Product?
Explore Our Spec Developer ELEVATOR® Services
The Spec Developer ELEVATOR® at NAGL MedTech™ is ideal for a client who needs development services for a medical device product. From early-stage concepts, through design controls, the NAGL MedTech™ team manages every aspect of the project to reach the company’s end goal.
Clients within the Spec Developer ELEVATOR® have access to Systems, Equipment, and Workforce services, and their projects are run within the NAGL MedTech™ quality system to ensure best-in-class products.
NAGL MedTech™ uses a tested, four-phase development strategy to help clients bring devices from early-stage concepts, through design controls, and beyond. Design qualifications, clinical validations, and regulatory submission and approval are all processes conducted within the Spec Developer ELEVATOR®.
The following NAGL MedTech™ Services are available and are tailored to design, develop, test, and completely validate your medical product.
Workforce
- World-class product development teams consisting of program managers, product development engineers, quality assurance engineers, regulatory/clinical support
- Product marketing support staff
Systems Access & Use
- Products will be developed utilizing NAGL MedTech’s™ proven quality and business systems – in keeping with the latest ISO and FDA guidance and regulations
- Product development software packages (i.e., SolidWorks, QT9, FEA Software)
Equipment & Facilities
- State-of-the-art R&D lab, clinical simulation lab for benchtop validations, 3D printing and prototyping areas, measuring equipment
- Packaging and labeling services
- Advanced catheter and balloon development equipment
- Validated ETO sterile cycle
- Calibration and maintenance of equipment
- Electrospinning equipment
